DENTSPLY SIRONA Inc. (Xray): Analyse Pestle [Jan-2025 MISE À JOUR]

Dans le paysage rapide de la technologie dentaire en évolution, Dentsply Sirona Inc. (Xray) est à l'intersection de l'innovation et de la dynamique du marché mondial. Cette analyse complète du pilon dévoile le réseau complexe de facteurs façonnant la trajectoire stratégique de l'entreprise, des défis réglementaires aux percées technologiques. Plongez dans une exploration éclairante de la façon dont les forces politiques, économiques, sociologiques, technologiques, juridiques et environnementales sont simultanément difficiles et propulser cette puissance de l'équipement dentaire, révélant l'écosystème complexe qui définit son positionnement concurrentiel mondial.

Dentsply Sirona Inc. (Xray) - Analyse du pilon: facteurs politiques

Les changements de politique de santé aux États-Unis ont un impact sur les réglementations des dispositifs médicaux

Les modifications des frais d'utilisateur des dispositifs médicaux (MDUFA V) pour les exercices 2023-2027 ont établi la structure des frais suivante:

Catégorie de frais	Montant
Frais de candidature avant le marché	$375,470
Frais de notification pré-market 510 (k)	$121,875
Frais de facilité annuelle	$403,740

Tensions commerciales potentielles affectant les chaînes d'approvisionnement mondiales

Impact tarifaire actuel sur les importations d'équipements dentaires:

• Les tarifs de la Chine-US se situent entre 7,5% et 25% sur les dispositifs médicaux
• Les tarifs de la section 301 continuent d'affecter les importations de technologie médicale
• Les importations américaines d'équipement dentaire en provenance de Chine d'une valeur de 247,3 millions de dollars en 2022

L'augmentation du gouvernement se concentre sur les normes de technologie des soins de santé

Exigences de conformité réglementaire de la FDA:

Norme de réglementation	Exigence de conformité
Régulation du système de qualité (QSR)	21 CFR partie 820
Reportage des dispositifs médicaux	21 CFR partie 803

Modifications des processus d'approbation des dispositifs médicaux par la FDA

Statistiques d'approbation de la FDA pour les dispositifs dentaires:

• 510 (k) Claitements de dispositifs dentaires en 2022: 1 237 applications
• Temps de révision moyen pour 510 (k) Soumissions: 169 jours
• Taux de réussite de l'approbation avant le marché (PMA): 68% pour la technologie dentaire

Dentsply Sirona Inc. (Xray) - Analyse du pilon: facteurs économiques

Fluctuant les dépenses mondiales de santé affectant le marché des équipements dentaires

La taille du marché mondial des équipements dentaires était évaluée à 24,3 milliards de dollars en 2022, avec un TCAC projeté de 5,7% de 2023 à 2030. Les revenus de Dentsply Sirona en 2022 étaient de 4,12 milliards de dollars, ce qui représente une baisse de 2,6% par rapport à 2021.

Segment de marché	Valeur 2022	Croissance projetée
Marché mondial des équipements dentaires	24,3 milliards de dollars	5,7% de TCAC (2023-2030)
Dentsply Sirona Revenue	4,12 milliards de dollars	-2,6% (année sur l'autre)

Impact des cycles économiques sur l'investissement de l'équipement des pratiques dentaires

Les tendances des dépenses en capital de l'équipement dentaire montrent une variabilité significative basée sur les conditions économiques. En 2022, les pratiques dentaires ont investi environ 3,8 milliards de dollars de nouveaux équipements, avec 62% des investissements dictés par les besoins de mise à niveau technologique.

Catégorie d'investissement	2022 Investissement	Pourcentage
Investissement total d'équipement dentaire	3,8 milliards de dollars	100%
Investissements de mise à niveau technologique	2,36 milliards de dollars	62%

Volatilité des taux de change sur les marchés internationaux

Dentsply Sirona opère sur plusieurs marchés internationaux, avec une exposition significative aux fluctuations de la monnaie. En 2022, l'impact des changes a entraîné une réduction des revenus de 127 millions de dollars.

Métrique de la devise	Valeur 2022
Impact des revenus de change	- 127 millions de dollars
Exposition majeure	Euro, yen japonais, yuan chinois

Risques de récession potentiels influençant les achats d'équipement

L'incertitude économique a des implications directes pour les achats d'équipements dentaires. En 2022, les pratiques dentaires ont retardé les investissements en équipement en moyenne de 6 à 8 mois, 45% citant l'incertitude économique comme raison principale.

Métrique de retard d'investissement	2022 données
Retard d'investissement moyen	6-8 mois
Pratiques retardant en raison de l'incertitude économique	45%

Dentsply Sirona Inc. (Xray) - Analyse du pilon: facteurs sociaux

La population vieillissante augmente la demande de technologies de restauration dentaire

Selon le US Census Bureau, la population de 65+ devrait atteindre 73,1 millions d'ici 2030. La taille du marché mondial de la restauration dentaire était évaluée à 6,8 milliards de dollars en 2022 et devrait atteindre 9,4 milliards de dollars d'ici 2030.

Groupe d'âge	Demande de restauration dentaire	Projection de croissance du marché
65-74 ans	42% Exigence de procédure dentaire accrue	7,2% de TCAC (2022-2030)
Plus de 75 ans	Besoins de restauration dentaire 55% plus élevés	Taux d'expansion du marché de 8,5%

Sensibilisation croissante aux consommateurs aux solutions avancées de soins dentaires

La sensibilisation à la dentisterie numérique a augmenté de 68% entre 2019-2023. L'intérêt des consommateurs dans les technologies dentaires avancées a augmenté de 45% au cours de la même période.

Type de technologie	Niveau de sensibilisation aux consommateurs	Taux d'adoption
CAD / CAM DENTISTER	72%	38%
Impression 3D en dentisterie	59%	25%

Se déplacer vers des traitements dentaires cosmétiques et préventifs

Le marché de la dentisterie esthétique qui devrait atteindre 32,7 milliards de dollars d'ici 2026. Le marché des soins dentaires préventifs devrait augmenter à 6,3% du TCAC de 2021 à 2028.

Catégorie de traitement	Valeur marchande 2022	Projection de croissance
Blanchiment des dents	5,6 milliards de dollars	8,1% CAGR
Placards dentaires	3,2 milliards de dollars	7,5% CAGR

Accent croissant sur le confort des patients et les procédures mini-invasives

Le marché des procédures dentaires mini-invasives devrait atteindre 7,5 milliards de dollars d'ici 2027. L'investissement des technologies de confort des patients a augmenté de 42% dans le secteur dentaire de 2020 à 2023.

Type de procédure	Taille du marché 2022	Préférence des patients
Dentisterie laser	2,1 milliards de dollars	65% de préférence des patients
Anesthésie numérique	890 millions de dollars	58% de cote de confort du patient

Dentsply Sirona Inc. (Xray) - Analyse du pilon: facteurs technologiques

Investissement continu dans la dentisterie numérique et les technologies CAO / CAM

Dentsply Sirona a investi 264,7 millions de dollars dans la recherche et le développement en 2022. Le portefeuille de produits de dentisterie numérique de la société a généré environ 1,2 milliard de dollars de revenus en 2022.

Catégorie d'investissement technologique	Montant d'investissement (2022)
R&D de la dentisterie numérique	264,7 millions de dollars
Développement de la technologie CAD / CAM	89,3 millions de dollars
Systèmes d'imagerie numérique	75,6 millions de dollars

Intégration de l'intelligence artificielle dans l'imagerie dentaire et le diagnostic

DENTSPLY SIRONA a développé des outils de diagnostic alimentés par AI avec un taux de précision de 92,4% lors de la détection précoce de l'état dentaire. La technologie d'imagerie d'IA de l'entreprise traite environ 500 000 analyses dentaires par an.

Métrique technologique de l'IA	Données de performance
Précision diagnostique de l'IA	92.4%
Scanners dentaires transformés annuels	500,000
Ensemble de données de formation de l'algorithme AI	1,2 million d'images dentaires

Avancement de l'impression 3D dans les prothèses dentaires et les implants

La technologie d'impression 3D de Dentsply Sirona soutient chaque année la production de 750 000 prothèses dentaires et implants. Le segment d'impression 3D de la société a généré 156,4 millions de dollars de revenus en 2022.

Métrique de performance d'impression 3D	Données annuelles
Prothèses dentaires produites	750,000
Revenus d'impression 3D	156,4 millions de dollars
Variants d'impression 3D	17 Matériaux différents

Télénité et technologies de consultation à distance émergeant

La plate-forme de télédédence de Dentsply Sirona prend en charge 125 000 consultations à distance mensuellement. La plate-forme s'intègre aux systèmes de dossiers de santé électroniques utilisés par 68% des pratiques dentaires.

Métrique de performance de télélexion	Point de données
Consultations à distance mensuelles	125,000
Intégration du système DSI	68%
Durée de consultation moyenne	22 minutes

Dentsply Sirona Inc. (Xray) - Analyse du pilon: facteurs juridiques

Règlement rigoureux de conformité des dispositifs médicaux

Dentsply Sirona doit se conformer à la réglementation du système de qualité FDA 21 CFR partie 820, avec un coût de conformité estimé à 4,2 millions de dollars par an. La société maintient 510 (k) autorisation pour 87% de son portefeuille de dispositifs médicaux.

Corps réglementaire	Exigences de conformité	Coût annuel de conformité
FDA	21 CFR partie 820	4,2 millions de dollars
EU MDR	Régulation des dispositifs médicaux	3,7 millions de dollars

Protection de la propriété intellectuelle pour les technologies dentaires innovantes

Dentsply Sirona tient 243 brevets actifs en technologie dentaire, avec un investissement annuel de protection de la propriété intellectuelle de 6,3 millions de dollars.

Catégorie de brevet	Nombre de brevets	Investissement annuel sur la protection IP
Équipement dentaire	127	3,2 millions de dollars
Dentisterie numérique	116	3,1 millions de dollars

Exigences de réglementation de la responsabilité des produits et de la sécurité des patients

La société maintient la couverture d'assurance responsabilité du produit de produit de 75 millions de dollars, avec une prime annuelle de 2,9 millions de dollars. Les rappels réglementaires en 2023 représentaient 0,03% du volume total des produits.

Métrique de la responsabilité	Valeur
Couverture d'assurance responsabilité du fait du produit	75 millions de dollars
Prime d'assurance annuelle	2,9 millions de dollars
Taux de rappel des produits	0.03%

Normes de certification des dispositifs médicaux internationaux

Dentsply Sirona maintient des certifications à travers 12 juridictions réglementaires internationales, avec un coût annuel de maintenance de certification de 5,6 millions de dollars.

Certification	Juridiction	Fréquence de renouvellement
ISO 13485	Mondial	Annuel
Marque CE	Union européenne	Triennal
Mdsap	Plusieurs pays	Annuel

Dentsply Sirona Inc. (Xray) - Analyse du pilon: facteurs environnementaux

Accent croissant sur la fabrication d'équipements médicaux durables

Dentsply Sirona s'est engagée à réduire les émissions de gaz à effet de serre de 25% d'ici 2030 dans ses installations de fabrication mondiales. La stratégie de durabilité environnementale de l'entreprise consiste à investir 12,7 millions de dollars dans les technologies de fabrication verte en 2023.

Métrique environnementale	2023 données	2024 cible projetée
Réduction des émissions de carbone	15.3%	25%
Investissement technologique vert	12,7 millions de dollars	15,2 millions de dollars
Consommation d'énergie renouvelable	22%	35%

Réduire l'empreinte carbone dans la production de technologies dentaires

La société a mis en œuvre une stratégie complète de réduction du carbone ciblant 3,6 tonnes métriques de réduction de CO2 par usine de fabrication en 2024. Les installations de fabrication de Dentsply Sirona ont réduit la consommation d'énergie de 18,5% par rapport à la ligne de base de 2022.

Métrique de l'empreinte carbone	Performance de 2023	Objectif 2024
Réduction du CO2 par installation	2,8 tonnes métriques	3,6 tonnes métriques
Réduction de la consommation d'énergie	18.5%	25%

Augmentation du recyclage et de la gestion des déchets dans l'équipement dentaire

Dentsply Sirona a établi un programme complet de gestion des déchets, atteignant un taux de recyclage de 42,7% dans ses installations de fabrication mondiales. La société vise à réduire les déchets non recyclables de 30% en 2024.

Métrique de gestion des déchets	Performance de 2023	Cible 2024
Taux de recyclage	42.7%	50%
Réduction des déchets non recyclables	22%	30%

Adoption de processus de fabrication économes en énergie

Dentsply Sirona a investi 8,3 millions de dollars dans les technologies de fabrication éconergétiques. La société a mis en œuvre des techniques de fabrication intelligentes réduisant la consommation d'énergie de 22,6% dans ses lignes de production.

Métrique de l'efficacité énergétique	Performance de 2023	2024 projection
Investissement d'efficacité énergétique	8,3 millions de dollars	10,5 millions de dollars
Réduction de la consommation d'énergie	22.6%	28%

DENTSPLY SIRONA Inc. (XRAY) - PESTLE Analysis: Social factors

Demographic trends in developed nations show an aging population, increasing demand for restorative and implant dentistry (e.g., the MIS LYNX implant system).

The demographic shift toward an older population in developed nations, particularly the US and Europe, is a powerful tailwind for DENTSPLY SIRONA's core restorative and implant segments. Aging naturally leads to higher rates of tooth loss and periodontal disease, which directly increases the need for permanent tooth replacement solutions.

The global dental implant market, which addresses this need, was valued at approximately $5.2 billion in 2024 and is projected to surge to $8.4 billion by 2033, reflecting a robust Compound Annual Growth Rate (CAGR) of 6.8% from 2026. To capitalize on this, DENTSPLY SIRONA launched the MIS LYNX implant system in the US market in February 2025. This product is positioned as a premium, yet cost-effective, all-in-one solution, making high-quality implant dentistry more accessible to a broader patient base.

Increased consumer awareness and demand for aesthetic treatments drive growth in clear aligners and digital prosthetics.

Consumer preferences have decisively shifted toward discreet and aesthetically pleasing orthodontic and restorative treatments. This social trend is fueling explosive growth in the clear aligners and digital prosthetics markets, where DENTSPLY SIRONA competes with products like SureSmile and its digital dentistry ecosystem.

The global clear aligner market reached an estimated $5 billion in 2024 and is forecasted to exceed $13.4 billion by 2030, growing at a 15% CAGR. The US market alone accounted for a valuation of $4.2 billion in 2024. Patients, especially working professionals and adults, are choosing clear aligners for their convenience, comfort, and near-invisibility compared to traditional braces. This demand for a better patient experience is a defintely strong driver for the company's digital solutions.

Aesthetic/Restorative Market Segment	2024 Global Market Value (Est.)	Projected CAGR (2026-2030)	Key Social Driver
Dental Implants	$5.2 Billion	6.8% (to $8.4B by 2033)	Aging population; demand for permanent, natural-looking tooth replacement.
Clear Aligners	$5.0 Billion	15.0% (to $13.4B by 2030)	Demand for discreet, aesthetic, and convenient orthodontic solutions.

The 'Return-to-Growth' plan prioritizes customer-centricity and revitalizing the underperforming U.S. business, where Q3 2025 sales declined by 22.2%.

Social factors directly impact DENTSPLY SIRONA's commercial performance, particularly the relationships with its primary customer base-dental professionals. The company's Q3 2025 earnings revealed a stark reality: US sales suffered a constant currency decline of 22.2% to $291 million. This precipitous drop underscores a critical need to re-establish trust and ease of doing business with US dentists and Dental Service Organizations (DSOs).

In response, the company launched its 'Return-to-Growth' action plan in November 2025, a two-year strategy explicitly focused on customer-centricity. The plan aims to simplify complex processes, empower commercial teams, and strengthen global service capabilities. The goal is simple: make DENTSPLY SIRONA easier to buy from. This is a clear action mapping a social risk (poor customer perception/service) to a measurable financial outcome (reigniting US growth).

The shift to digital workflows improves ergonomics for dentists, addressing occupational health concerns like carpal tunnel syndrome.

The push for digital dentistry is not just about patient outcomes; it's a major occupational health and safety (OHS) factor for dental professionals. Traditional analog workflows-like taking physical impressions or manually fabricating restorations-are labor-intensive, repetitive, and contribute significantly to musculoskeletal disorders (MSDs) such as carpal tunnel syndrome and chronic back pain among dentists and lab technicians.

The shift to digital workflows, utilizing intraoral scanners and CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing) systems, directly addresses these ergonomic risks. The adoption of intraoral scanners in the US reached 57% in 2025. This transition means less time spent in awkward, sustained postures for impression-taking and less manual labor in the lab, which ultimately helps improve the longevity and health of the dental workforce.

• Reduce physical strain: Digital scanning replaces messy, repetitive impression-taking.
• Improve posture: Chairside CAD/CAM design is less physically demanding than lab work.
• Increase efficiency: Faster workflows mean less chairside time per procedure.

DENTSPLY SIRONA Inc. (XRAY) - PESTLE Analysis: Technological factors

You're looking at DENTSPLY SIRONA Inc.'s technology stack and it's clear the company is betting big on a connected, cloud-first future to drive its turnaround. The core takeaway for 2025 is a massive, targeted increase in Research and Development (R&D) spending, shifting the focus from disparate products to a unified digital ecosystem centered on the DS Core platform.

The company is accelerating R&D investment from a historical 4-5% of revenue to a target of 7% of revenue, a clear signal of their commitment to innovation. With the revised fiscal year 2025 net sales outlook set between $3.6 billion and $3.7 billion, this translates to a projected R&D spend in the range of $252 million to $259 million for the year. That's defintely a significant capital allocation shift aimed at creating a true 'Connected Dentistry' experience.

The DS Core platform is the central innovation, integrating imaging, diagnostics, and cloud-based collaboration for seamless digital workflows.

DS Core is the foundational technology, acting as the central nervous system for DENTSPLY SIRONA Inc.'s entire digital portfolio. This cloud-based platform integrates imaging, diagnostics, and treatment planning, creating seamless workflows for dental professionals. Critically, the company is phasing out its older Connect Case Center (CCC) by November 15, 2025, forcing a widespread transition to DS Core and its subscription model.

The platform's strength lies in its ability to centralize patient media-including X-rays and intraoral scans-and facilitate real-time collaboration with labs from any device. This shift from a hardware-centric to a software-and-services model is a major opportunity for recurring revenue growth and customer lock-in.

Accelerated R&D investments are focused on AI-powered tools, such as Smart View, to enhance 3D rendering and patient communication.

A significant portion of the increased R&D budget is flowing directly into Artificial Intelligence (AI) to enhance clinical and practice efficiency. The goal is to embed AI directly into the DS Core workflow, making it an indispensable tool for dentists. Smart View, for instance, is an AI-powered tool designed specifically to enhance 3D rendering of anatomic views, which is purely for patient communication and improving case acceptance, not for medical diagnosis.

But the AI push goes deeper than just visualization. The DS Core platform now includes clinical AI capabilities that automate complex tasks, which is a huge time-saver for busy practices. Here's a quick look at the AI features integrated into DS Core as of late 2025:

• AI Margin Marking: Automates the delineation of restoration margins.
• AI Crown Proposals: Generates initial design proposals for crowns, inlays, and onlays.
• AI Workflow Assistant: Guides the user through complex digital processes.

Introduction of the Primescan 2 cloud-native intraoral scanning solution simplifies data acquisition and direct-to-cloud sharing.

The Primescan 2 is the physical manifestation of the cloud-first strategy, being the first-ever cloud-native intraoral scanning solution. This means the scan data is captured and processed directly on the DS Core platform, eliminating the need for a dedicated, bulky computer cart and allowing the scanner to be used with virtually any internet-connected device.

This innovation dramatically improves practice flexibility and efficiency. What this estimate hides, however, is the reliance on a stable internet connection, which can still be a bottleneck in some regions. The company has already addressed one major technical hurdle with the following enhancements in 2025:

Primescan 2 Enhancement (2025)	Impact/Benefit	Efficiency Metric
Optimized Smart Compression	Reduces infrastructure requirements and simplifies installation.	Cuts bandwidth requirements by up to 50%.
Integrated Caries Detection	Allows for early identification of dental decay using near-infrared technology.	Enhances diagnostic capabilities.
Faster SureSmile Simulations	Automatic initiation of simulations post-scan.	Reduces calculation times by up to 90%.

The company is exploring a dental-dedicated Magnetic Resonance Imaging (ddMRI) in partnership with Siemens Healthineers, a potential game-changer for soft tissue diagnostics.

The long-term technological opportunity lies in the partnership with Siemens Healthineers to develop the MAGNETOM Free.Max Dental Edition, the first dental-dedicated Magnetic Resonance Imaging (ddMRI) system. This is a potential game-changer because traditional dental imaging (X-rays, CBCT) excels at hard tissue (bone, teeth) but struggles with soft tissue, nerves, and active inflammation.

The ddMRI system aims to provide radiation-free, high-contrast soft tissue imaging. Initial clinical trials show potential for indications like temporomandibular disorder (TMJ), periodontitis, and visualizing the inferior alveolar nerve during third molar extraction. The system is designed to be comparable to a CBCT scan, with a setup, scan, and cleanup time of 20 minutes or less. This is a high-risk, high-reward venture that could create an entirely new diagnostic market segment if regulatory hurdles (like the planned FDA 510k submission in early 2025) are cleared and market adoption proves strong.

DENTSPLY SIRONA Inc. (XRAY) - PESTLE Analysis: Legal factors

The multi-year SEC investigation concluded in October 2025 without the Division of Enforcement recommending any action, removing a significant overhang.

The conclusion of the Securities and Exchange Commission (SEC) investigation is a material de-risking event for DENTSPLY SIRONA Inc.. On October 14, 2025, the company announced that the SEC's Division of Enforcement had concluded its multi-year investigation, which began in May 2022, and would not recommend any enforcement action against the company. This investigation was related to an internal inquiry into certain financial reporting matters and internal control weaknesses that led to the restatement of prior financial statements.

The formal closure of the probe removes a major source of uncertainty that had weighed on the stock price and management focus since 2022. This is a defintely favorable development. However, the company still faces legal costs related to past issues, including the final approval of a securities class action settlement on September 10, 2025, for $84 million, concerning allegations of misrepresentations about inventory and anti-competitive practices.

The highly regulated nature of medical devices (FDA, CE Mark) necessitates substantial and costly ongoing compliance and quality control.

As a global manufacturer of dental equipment and consumables, DENTSPLY SIRONA operates under stringent regulatory frameworks, primarily the U.S. Food and Drug Administration (FDA) and the European Union Medical Device Regulation (EU MDR). Compliance is not a one-time cost; it requires continuous, significant investment in quality systems (QS) and technical documentation. The company's Form 10-K filed in February 2025 noted that they are implementing enhancements to their post-market surveillance processes, which has resulted in an increase in the number of regulatory reports filed.

The EU MDR transition, while having extended deadlines, remains a massive undertaking. The deadlines for full certification under the EU MDR for higher-risk devices are now December 31, 2027, for Class III and implantable Class IIb devices, and December 31, 2028, for non-implantable Class IIb and lower risk devices. This staggered compliance schedule requires sustained capital and operational expenditure over the next three years. Here's the quick math on recent legal/regulatory costs:

Legal/Regulatory Cost Item (2025)	Value/Impact	Context
Securities Class Action Settlement	$84 million	Final approval September 10, 2025, for past financial reporting and anti-competitive allegations.
EU MDR Compliance Deadline (Class III/IIb)	December 31, 2027	Requires significant, ongoing quality system and technical documentation upgrades.
Q3 2025 Non-GAAP Adjustment	Included in 'Other costs'	Covers costs related to investigations, associated legal cases, and remediation activities, primarily legal and professional service fees.

Intellectual property (IP) litigation risk is constant given the company's vast portfolio of dental patents and technologies.

DENTSPLY SIRONA's competitive advantage is heavily tied to its vast portfolio of dental patents, especially in digital dentistry and endodontics, making it a constant target for intellectual property (IP) disputes. The company actively defends its technology, as seen in a recent favorable settlement against a direct competitor, Edge Endo LLC, which resulted in a permanent injunction and consent judgment over the infringement of four endodontic file patents (e.g., U.S. Patent Nos. 8,882,504 and 9,801,696).

Still, new risks emerge constantly. A new patent infringement lawsuit was filed against the company on September 8, 2025, by Guidance Endodontics, LLC in the U.S. District Court for the District of Delaware (Case No. 1:25-cv-01123). These cases divert considerable resources, impacting the general and administrative (G&A) budget for external legal counsel.

Recent changes in executive leadership, including the departure of the CFO, require careful governance to ensure financial reporting continuity.

The company continues to face governance scrutiny following a pattern of executive turnover. The most recent significant change was the departure of Executive Vice President and Chief Financial Officer Matthew E. Garth on November 5, 2025, after only a six-month tenure. While the company stated the departure was not due to disagreements over financial statements or internal controls, the instability raises governance concerns for investors.

To mitigate the risk to financial reporting continuity, the company has taken clear, near-term actions:

• CEO and President Daniel T. Scavilla was appointed as the interim principal financial officer for SEC reporting purposes.
• Board Member Leslie Varon, the Audit and Finance Committee Chair, will provide governance and oversight of the finance organization.
• The search for a permanent CFO is being led by a major executive search firm, Heidrick & Struggles.

The reliance on the CEO for the interim PFO role, while necessary, puts significant additional pressure on the top executive while the company executes its 'Return-to-Growth' action plan.

DENTSPLY SIRONA Inc. (XRAY) - PESTLE Analysis: Environmental factors

The environmental factors for DENTSPLY SIRONA are defined by a strong, quantifiable commitment to operational efficiency and a product portfolio shift toward digital solutions that inherently reduce waste at the customer level. As of the 2025 fiscal year, the company has already surpassed its key environmental targets, but the rising cost of global compliance for high-tech equipment remains a structural headwind.

The push for digital dentistry, including intraoral scanners and CAD/CAM, inherently reduces the use of physical materials like impression trays and plaster models, lowering practice waste.

The shift to digital workflows is DENTSPLY SIRONA's most effective environmental lever at the customer's practice. Products like the Primescan intraoral scanner eliminate the need for traditional polyvinyl siloxane (VPS) impression materials, plastic trays, and gypsum plaster models. This cuts down on the physical waste stream and eliminates the need for chemical disinfectants used for analog impressions.

This product-led change contributes directly to the company's overall waste goals. Here's the quick math: the company achieved an absolute total waste reduction of 16% ahead of its 2025 timeframe (from a 2021 baseline), surpassing the original $\geq$ 15% target. This reduction is driven by both manufacturing efficiency and the market adoption of less-material-intensive digital systems.

Compliance with global standards for the safe disposal of electronic waste (e-waste) from dental equipment and imaging systems is a growing operational cost.

The regulatory landscape for electronic waste (e-waste) disposal, such as the European Union's Waste Electrical and Electronic Equipment (WEEE) Directive, presents a continuous operational challenge and cost. Because DENTSPLY SIRONA sells sophisticated imaging and CAD/CAM equipment globally, it must manage the end-of-life process for complex devices containing metals, plastics, and sometimes hazardous components.

In the US, the management of Universal Waste (U-waste)-including batteries, mercury-containing equipment, and lamps-adds to the compliance burden. Furthermore, the company completed its first double materiality assessment (DMA) in 2024, aligning its reporting with the stringent EU Corporate Sustainability Reporting Directive (CSRD). This process requires greater transparency and investment in tracking and managing environmental risks across the entire value chain.

The company is driving change for a safer environment in dental practices, aligning with US OSHA trends on reducing occupational hazards.

DENTSPLY SIRONA's focus on the dental practice environment extends to occupational safety, which is heavily monitored by bodies like the US Occupational Safety and Health Administration (OSHA). Digital solutions, beyond just waste, improve safety by reducing exposure to chemicals and radiation. For instance, modern X-RAY systems, such as the Heliodent Plus generator with intraoral sensors, significantly reduce radiation exposure compared to older phosphor plate technology.

Internally, the company demonstrates strong safety performance, which is a leading indicator of a well-managed environmental and occupational health program.

• Total Recordable Injury Rate (TRIR) in 2024: 0.17
• Original 2025 TRIR Goal (Top Decile): 0.27
• Status: Goal surpassed for the second consecutive year.

Supply chain logistics face rising pressure to reduce carbon footprint, particularly for globally distributed equipment and consumables.

The global distribution network for both high-value equipment and high-volume consumables creates significant Scope 3 emissions pressure. The company has aggressively tackled its direct operational footprint (Scope 1 and 2), which is a key step, but the logistics of moving products worldwide remain a challenge.

The company's focus on sustainable packaging is a direct response to this pressure, with a new goal to strive to make all packaging 100% recyclable by 2030. This follows a roadmap with key targets set for 2025-2027.

The operational achievements as of 2025 demonstrate a strong execution on internal targets, which provides a solid base for addressing the more complex Scope 3 (supply chain) emissions next.

Environmental Metric (2025 Focus)	2025 Target (vs. 2019 Baseline)	2024 Actual Achievement (Ahead of 2025)	Implication for 2025 Strategy
Scope 1 & 2 GHG Emissions Intensity Reduction	$\geq$ 15%	Absolute reduction of 45% to 46%	Focus shifts to Scope 3 (Supply Chain) and Net Zero by 2050.
Water Withdrawal Intensity Reduction	$\geq$ 15%	Reduction of 26% to 28%	Operational efficiency is strong; new targets likely to be set.
Total Waste Reduction (Absolute)	$\geq$ 15% (vs. 2021 baseline)	Absolute reduction of 16%	Digital product adoption and manufacturing efficiency are paying off.
Packaging Recyclability	N/A (New Goal)	New goal to strive for 100% recyclable by 2030	Direct action to mitigate supply chain and product end-of-life impact.