Análisis PESTLE de DENTSPLY SIRONA Inc. (XRAY) [Actualizado en enero de 2025]

En el panorama de tecnología dental en rápida evolución, Dentsply Sirona Inc. (XRAY) se encuentra en la intersección de la innovación y la dinámica del mercado global. Este análisis integral de la mano presenta la compleja red de factores que dan forma a la trayectoria estratégica de la compañía, desde los desafíos regulatorios hasta los avances tecnológicos. Sumérgete en una exploración esclarecedora de cómo las fuerzas políticas, económicas, sociológicas, tecnológicas, legales y ambientales están desafiando y impulsando simultáneamente esta potencia de equipo dental hacia adelante, revelando el intrincado ecosistema que define su posicionamiento competitivo global.

Dentsply Sirona Inc. (xray) - Análisis de mortero: factores políticos

Política de salud de los Estados Unidos cambia las regulaciones de dispositivos médicos de impacto

Las enmiendas de tarifas del usuario del dispositivo médico (MDUFA V) para los años fiscales 2023-2027 establecieron la siguiente estructura de tarifas:

Categoría de tarifa	Cantidad
Tarifa de solicitud previa al mercado	$375,470
Notificación previa a la tarifa 510 (k)	$121,875
Tarifa de la instalación anual	$403,740

Tensiones comerciales potenciales que afectan las cadenas de suministro de equipos dentales globales

Impacto arancelario actual en las importaciones de equipos dentales:

• Los aranceles de China-US oscilan entre 7.5% y 25% en dispositivos médicos
• La Sección 301 las tarifas continúan afectando las importaciones de tecnología médica
• Importaciones estadounidenses de equipos dentales de China valoradas en $ 247.3 millones en 2022

Aumento del enfoque del gobierno en los estándares de tecnología de salud

Requisitos de cumplimiento regulatorio de la FDA:

Reglamentario	Requisito de cumplimiento
Regulación del sistema de calidad (QSR)	21 CFR Parte 820
Informes de dispositivos médicos	21 CFR Parte 803

Cambios en los procesos de aprobación del dispositivo médico por la FDA

Estadísticas de aprobación de la FDA para dispositivos dentales:

• 510 (k) Agrupaciones para dispositivos dentales en 2022: 1,237 aplicaciones
• Tiempo de revisión promedio para 510 (k) presentaciones: 169 días
• Tasa de éxito de aprobación previa a la comercialización (PMA): 68% para tecnología dental

Dentsply Sirona Inc. (xray) - Análisis de mortero: factores económicos

Fluctuando el gasto mundial de atención médica que afecta el mercado de equipos dentales

El tamaño del mercado mundial de equipos dentales se valoró en $ 24.3 mil millones en 2022, con una tasa compuesta anual proyectada de 5.7% de 2023 a 2030. Los ingresos de Dentsply Sirona en 2022 fueron de $ 4.12 mil millones, lo que representa una disminución del 2.6% de 2021.

Segmento de mercado	Valor 2022	Crecimiento proyectado
Mercado global de equipos dentales	$ 24.3 mil millones	5,7% de CAGR (2023-2030)
Dentsply Sirina Ingresos	$ 4.12 mil millones	-2.6% (año tras año)

Impacto de los ciclos económicos en la inversión de equipos de prácticas dentales

Las tendencias de gasto de capital de equipos dentales muestran una variabilidad significativa basada en condiciones económicas. En 2022, las prácticas dentales invirtieron aproximadamente $ 3.8 mil millones en nuevos equipos, con el 62% de las inversiones impulsadas por las necesidades de actualización tecnológica.

Categoría de inversión	2022 inversión	Porcentaje
Inversión total de equipos dentales	$ 3.8 mil millones	100%
Inversiones de actualización de tecnología	$ 2.36 mil millones	62%

Volatilidad del tipo de cambio de divisas en los mercados internacionales

Dentsply Sirona opera en múltiples mercados internacionales, con una exposición significativa a las fluctuaciones monetarias. En 2022, el impacto de divisas resultó en una reducción de ingresos de $ 127 millones.

Metría métrica	Valor 2022
Impacto de los ingresos por divisas	-$ 127 millones
Exposición monetaria mayor	Euro, yen japonés, yuan chino

Riesga potencial de la recesión influyendo en las compras de equipos de capital

La incertidumbre económica tiene implicaciones directas para las compras de equipos dentales. En 2022, las prácticas dentales retrasaron las inversiones de equipos de capital en un promedio de 6-8 meses, con un 45% citando la incertidumbre económica como la razón principal.

Métrica de retraso de inversión	Datos 2022
Retraso de inversión promedio	6-8 meses
Prácticas retrasándose debido a la incertidumbre económica	45%

Dentsply Sirona Inc. (xray) - Análisis de mortero: factores sociales

La población envejecida aumenta la demanda de tecnologías de restauración dental

Según la Oficina del Censo de EE. UU., Se proyecta que la población de más de 65 años alcanzará los 73.1 millones para 2030. El tamaño del mercado mundial de restauración dental se valoró en $ 6.8 mil millones en 2022 y se espera que alcance los $ 9.4 mil millones para 2030.

Grupo de edad	Demanda de restauración dental	Proyección de crecimiento del mercado
65-74 años	42% Aumento del requisito de procedimiento dental	7.2% CAGR (2022-2030)
Más de 75 años	Necesidades de restauración dental 55% más altas	Tasa de expansión del mercado de 8.5%

Conciencia del consumidor creciente sobre las soluciones avanzadas de cuidado dental

La conciencia de odontología digital aumentó en un 68% entre 2019-2023. El interés del consumidor en tecnologías dentales avanzadas aumentó un 45% en el mismo período.

Tipo de tecnología	Nivel de conciencia del consumidor	Tasa de adopción
Odontología CAD/CAM	72%	38%
Impresión 3D en odontología	59%	25%

Cambiar hacia tratamientos dentales cosméticos y preventivos

El mercado de odontología cosmética proyectada para llegar a $ 32.7 mil millones para 2026. Se espera que el mercado de atención dental preventiva crezca a un 6,3% CAGR de 2021-2028.

Categoría de tratamiento	Valor de mercado 2022	Proyección de crecimiento
Blanqueamiento de los dientes	$ 5.6 mil millones	8.1% CAGR
Carillas dentales	$ 3.2 mil millones	7,5% CAGR

Aumento del énfasis en la comodidad del paciente y los procedimientos mínimamente invasivos

Se espera que el mercado de procedimientos dentales mínimamente invasivos alcance los $ 7.5 mil millones para 2027. La inversión en tecnologías de confort del paciente aumentó en un 42% en el sector dental desde 2020-2023.

Tipo de procedimiento	Tamaño del mercado 2022	Preferencia del paciente
Odontología con láser	$ 2.1 mil millones	65% de preferencia del paciente
Anestesia digital	$ 890 millones	58% Calificación de confort del paciente

Dentsply Sirona Inc. (xray) - Análisis de mortero: factores tecnológicos

Inversión continua en odontología digital y tecnologías CAD/CAM

Dentsply Sirona invirtió $ 264.7 millones en investigación y desarrollo en 2022. La cartera de productos de odontología digital de la compañía generó aproximadamente $ 1.2 mil millones en ingresos en 2022.

Categoría de inversión tecnológica	Monto de inversión (2022)
I + D de odontología digital	$ 264.7 millones
Desarrollo de tecnología CAD/CAM	$ 89.3 millones
Sistemas de imágenes digitales	$ 75.6 millones

Integración de inteligencia artificial en imágenes y diagnósticos dentales

Dentsply Sirona ha desarrollado herramientas de diagnóstico con AI con una tasa de precisión del 92.4% en la detección de condiciones dentales tempranas. La tecnología de imagen AI de la compañía procesa aproximadamente 500,000 escaneos dentales anualmente.

Métrica de tecnología de IA	Datos de rendimiento
AI Precisión diagnóstica	92.4%
Escaneos dentales procesados ​​anuales	500,000
Conjunto de datos de capacitación de algoritmo AI	1.2 millones de imágenes dentales

Avances de impresión 3D en prótesis e implantes dentales

La tecnología de impresión 3D de Dentsply Sirona admite la producción de 750,000 prótesis dentales e implantes anualmente. El segmento de impresión 3D de la compañía generó $ 156.4 millones en ingresos en 2022.

Métrica de rendimiento de impresión 3D	Datos anuales
Prótesis dental producida	750,000
Ingresos de impresión 3D	$ 156.4 millones
Variantes de material de impresión 3D	17 materiales diferentes

TeledeTrys y tecnologías de consulta remota emergentes

La plataforma TeledEntistry de Dentsply Sirona admite 125,000 consultas remotas mensualmente. La plataforma se integra con los sistemas de registros de salud electrónicos utilizados por el 68% de las prácticas dentales.

Métrica de rendimiento de teledEtentica	Punto de datos
Consultas remotas mensuales	125,000
Integración del sistema EHR	68%
Duración de consulta promedio	22 minutos

Dentsply Sirona Inc. (xray) - Análisis de mortero: factores legales

Regulaciones estrictas de cumplimiento de dispositivos médicos

Dentsply Sirona debe cumplir con la regulación del sistema de calidad FDA 21 CFR Parte 820, con un costo de cumplimiento estimado de $ 4.2 millones anuales. La compañía mantiene la autorización de 510 (k) para el 87% de su cartera de dispositivos médicos.

Cuerpo regulador	Requisitos de cumplimiento	Costo de cumplimiento anual
FDA	21 CFR Parte 820	$ 4.2 millones
MDR de la UE	Regulación de dispositivos médicos	$ 3.7 millones

Protección de propiedad intelectual para tecnologías dentales innovadoras

Dentsply Sirona sostiene 243 patentes activas en tecnología dental, con una inversión anual de protección de propiedad intelectual de $ 6.3 millones.

Categoría de patente	Número de patentes	Inversión anual de protección de IP
Equipo dental	127	$ 3.2 millones
Odontología digital	116	$ 3.1 millones

Responsabilidad del producto y requisitos regulatorios de seguridad del paciente

La compañía mantiene la cobertura de seguro de responsabilidad civil del producto de $ 75 millones, con una prima anual de $ 2.9 millones. Los retiros regulatorios en 2023 representaron el 0.03% del volumen total del producto.

Métrico de responsabilidad	Valor
Cobertura de seguro de responsabilidad civil del producto	$ 75 millones
Prima de seguro anual	$ 2.9 millones
Tasa de retiro de productos	0.03%

Normas internacionales de certificación de dispositivos médicos

Dentsply Sirona mantiene certificaciones entre 12 jurisdicciones regulatorias internacionales, con un costo de mantenimiento de certificación anual de $ 5.6 millones.

Proceso de dar un título	Jurisdicción	Frecuencia de renovación
ISO 13485	Global	Anual
Marca	unión Europea	Trienal
Mdsap	Múltiples países	Anual

Dentsply Sirona Inc. (xray) - Análisis de mortero: factores ambientales

Concentativo creciente en la fabricación de equipos médicos sostenibles

Dentsply Sirona se ha comprometido a reducir las emisiones de gases de efecto invernadero en un 25% para 2030 en sus instalaciones de fabricación globales. La estrategia de sostenibilidad ambiental de la compañía implica invertir $ 12.7 millones en tecnologías de fabricación ecológica en 2023.

Métrica ambiental	2023 datos	2024 objetivo proyectado
Reducción de emisiones de carbono	15.3%	25%
Inversión en tecnología verde	$ 12.7 millones	$ 15.2 millones
Uso de energía renovable	22%	35%

Reducción de la huella de carbono en la producción de tecnología dental

La compañía ha implementado una estrategia integral de reducción de carbono dirigida a 3.6 toneladas métricas de reducción de CO2 por instalación de fabricación en 2024.

Métrica de huella de carbono	2023 rendimiento	Meta de 2024
Reducción de CO2 por instalación	2.8 toneladas métricas	3.6 toneladas métricas
Reducción del consumo de energía	18.5%	25%

Aumento del reciclaje y gestión de residuos en equipos dentales

Dentsply Sirona ha establecido un programa integral de gestión de residuos, logrando una tasa de reciclaje del 42.7% en sus instalaciones de fabricación global. La compañía tiene como objetivo reducir los desechos no reciclables en un 30% en 2024.

Métrica de gestión de residuos	2023 rendimiento	Objetivo 2024
Tasa de reciclaje	42.7%	50%
Reducción de residuos no reciclables	22%	30%

Adopción de procesos de fabricación de eficiencia energética

Dentsply Sirona ha invertido $ 8.3 millones en tecnologías de fabricación de eficiencia energética. La compañía ha implementado técnicas de fabricación inteligentes que reducen el consumo de energía en un 22,6% en sus líneas de producción.

Métrica de eficiencia energética	2023 rendimiento	2024 proyección
Inversión de eficiencia energética	$ 8.3 millones	$ 10.5 millones
Reducción del consumo de energía	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.