Ethical Business Conduct

We are committed to running an ethical and transparent business, and work hard to foster trusted relationships with our employees, customers, partners and shareholders.

We strive for the highest standards of excellence throughout our operations and we are increasing transparency around our ESG reporting. To achieve this, we engage with our stakeholders to understand the most material sustainability issues facing the business so we can take positive, long-lasting action to create a brighter world. This is evidenced by the integration of ESG and sustainability issues into our annual enterprise risk assessment to identify, prioritize and respond to the main risks facing the business as well as our first materiality assessment.

Our people sit at the heart of our business, so a healthy business, to us, means integrating sustainable, inclusive, and equitable practices across all aspects of our business to create a supportive working environment. In line with this, we have repositioned our global target of striving to achieve gender pay parity by 2025 under our Healthy Business strategy, to sit alongside our commitment to embed ESG factors across all our risk management processes.

People are central to our business, so we operate in line with the UN International Labor Organization’s Declaration on Fundamental Principles and Rights at Work. We strongly support freedom of association and the effective recognition of the right to collective bargaining, the elimination of forced or compulsory labor, the abolition of child labor and the elimination of discrimination in respect of employment

We take an active global approach to eliminate any issues surrounding exploitation, slavery, and human trafficking through internal policies as well as through direct actions with business partners in our supply chain. These policies include our Business Partner Code of Conduct. We expect all employees and business partners to fully comply with the California Transparency in Supply Chain Act of 2010 and the UK Modern Slavery Act of 2015, the Australian Modern Slavery Act, the New South Wales Modern Slavery Act, the Uyghur Forced Labor Prevention Act and the Conflict Minerals provisions of the US Dodd-Frank Act of 2010.

To mitigate the risks posed by cybersecurity incidents and cyberattacks, we have developed a program to protect the confidentiality, integrity, and continued availability of our data and systems.

Additionally, the program ensures ongoing compliance with the various external regulatory requirements related to data privacy and security.

This program includes a cybersecurity incident response plan and a suite of policies and standards that align with various cyber control frameworks including ISO27001, COBIT, and NIST. Different elements of these controls are evaluated annually by multiple third-party information security firms and our controls are adjusted as needed. All global IT staff and contractors receive training on these policies annually. Additionally, all internal system users receive annual training on information security and certain business functions with access to critical data elements receive continual anti-phishing assessments and training. 

The Board and the Audit and Finance Committee oversee our management of cybersecurity risk. Our Chief Information Officer provides regular updates on this program at multiple points throughout the year to the Board and the Audit and Finance Committee, including updates on cyber risk management governance and the status of cybersecurity control strengthening projects.

The Audit and Finance Committee regularly briefs the full Board on cybersecurity issues, and the Chief Information Officer provides quarterly and ad-hoc briefings on our cybersecurity program.
Responding to the fast-evolving technology landscape, we also continue to adapt our cybersecurity protocols and processes. Our Privacy Policy outlines the different types of personal data we collect, the legal grounds for doing so, and how it is used. 

The Company has experienced information security breaches within the last three years, including in 2022, however these incidents have been immaterial including from a net expense perspective and the Company has not paid any penalties or settlements in connection with such immaterial breaches. Additionally, the Company currently maintains an information security risk insurance policy.

Every year we obtain numerous 510K clearances for our products. A 510K is a premarketing submission made to the FDA to demonstrate that the device to be marketed is safe and effective, or substantially equivalent (SE) to a legally marketed device that is not subject to premarket approval (PMA).

We voluntarily conducted one significant product recall in 2020. The product recall was notified to FDA and has been completed. It pertained to one of our urinary catheter products: a very small number of units were potentially deformed.

Our Product Safety Program includes the following:

• A Complaints Management program that collects, monitors and investigates product complaints.
• A robust Post-Market Surveillance Process in place for each product group, to ensure compliance with applicable PMS requirements.
• A Risk Management program that covers design, manufacturing, and post-market surveillance.
• An extensive product testing program used throughout the lifecycle of the product, that includes design, validation and verification, in-process and finished product testing.
• A Quality Management System bespoke to each manufacturing entity, which governs safety, quality and compliance
• A Quality Management System-related training program where personnel involved in R&D, manufacturing and quality control are trained to carry out their responsibilities.
  

Our facilities are certified as appropriate to ISO 13485, EU Medical Device Directive (MDD), EU Medical Device Regulation (MDR), MDSAP (Medical Device Single Audit Program), and we comply with FDA QSR 820 as well as other country-specific regulatory requirements.

• Sites Certified to ISO 13485/9001: 36
• Sites Certified to MDD: 27
• Sites Certified to MDR: 15 

Pre-clinical & clinical testing

Dentsply Sirona develops and licenses numerous medical devices for use in dental care applications. We strive to develop innovations that represent significant improvements to the status quo. Whenever possible, Dentsply Sirona uses in-vitro or benchtop methods that do not require testing on animals.

Prior to commercializing innovative products, Dentsply Sirona often utilizes data from human clinical tests. The Company conducts all studies with human subjects in a manner that protects the safety and rights of patients and investigators. In addition to protecting the rights of individuals, including confidentiality, we comply with regulatory requirements of the countries in which studies are conducted and those in which regulatory submissions take place. Its practice ensures that controls are in place and followed to protect the integrity of the study results.

Dentsply Sirona’s policy clearly states that no Company funds or other Company assets may be contributed for political purposes without the prior review and consent of our General Counsel. We believe that telehealth and/or teledentistry will be a prominent topic in state legislatures, which has the potential to affect Byte’s business model. As a result, Byte has a government affairs team that leads its engagement in the legislative and regulatory process at all levels of government to advance responsible policies that are aligned with Byte’s mission to increase access to oral health care. Byte’s participation in the policymaking process is guided by Dentsply Sirona’s core values and in compliance with applicable laws that require reporting on lobbying and related activities. In 2021, Byte made $115,000 in political contributions to promote the interests of the Company and support policies that provide customers access to safe and affordable options for oral health care.

Dentsply Sirona is a member of several US dental trade associations including the Dental Trade Alliance (“DTA”). The DTA provides dental equipment, supplies, materials and services to dentists and other oral care professionals and may, occasionally, engage in lobbying regarding legislation that is of interest to its members.