Ethical Business Conduct

Our Ethical Customer Interaction Policy requires that all interactions with medical and dental professionals are compliant with applicable laws and regulations, as well as our own values.

We are proud to go beyond strict legal regulations to follow the highest ethical standards when interacting with healthcare professionals and institutions, and disclose the total annual amount of monetary losses as a result of legal proceedings associated with false marketing claims.

We mandate regular training on this policy to all employees who interact with healthcare professionals including our entire sales and marketing teams. The training is based on the ADVAMED Code, which formed the foundation of the Ethical Customer Interaction Policy, and includes specific guidance on adhering to the U.S. Anti-Kickback Statute, the Physician Payments Sunshine Act (Open Payments), and other transparency laws worldwide.

Our Business Partner Code of Conduct defines the expectations for all business partners (Distributors, Consultants and Suppliers), ensuring that we partner with businesses which share our values and desire to conduct business in an ethical and lawful manner. We maintain a stringent process to evaluate our suppliers and ensure each supplier complies with our high ethical and legal standards.

In line with the UN International Labor Organization’s Declaration on Fundamental Principles and Rights at Work, we 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.

Dentsply Sirona supports global efforts to address the issues of exploitation, slavery, and human trafficking through internal policies as well as through direct actions with business partners. We expect all employees and business partners to fully comply with the California Transparency in Supply Chain Act of 2010, the U.K. Modern Slavery Act of 2015, the Australian Modern Slavery Act, the New South Wales Modern Slavery Act, and the Conflict Minerals provisions of the U.S. 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. 

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: 34
• Sites Certified to MDD: 24
• Sites Certified to MDR: 2
  

The number of certifications to MDR will significantly increase over 2021.

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.

In 2020, Dentsply Sirona did not use corporate funds for political spending or lobbying on political issues. In line with our policy, no Company funds or other Company assets may be contributed for political purposes without the prior review and consent of our General Counsel. We do not have a political action committee.

In the U.S., Dentsply Sirona is a member of various dental trade associations, such as the Dental Trade Alliance (DTA), an association that provides dental equipment, supplies, materials, and services to dentists and other oral care professionals. The DTA’s core purpose is to enhance member success and increase dental demand. Occasionally, the DTA may engage in lobbying regarding legislation that is of interest to its members.

On December 31, 2020, Dentsply Sirona acquired Byte. This disclosure does not take into account activities that may have been conducted by Byte in 2020.

We have multiple programs in place to support product accessibility. In low-income countries (LICs) and lower-middle-income countries (LMICs), we operate with a different price list for our main, established and older product lines, providing a price level of up to 30% below our regular price level in developed core markets.

In terms of how price information for each product is disclosed to customers or agents, we communicate all updates on price information to our customers and distributors electronically, 6 to 8 weeks in advance of the change. Changes include a new price book or amendment to contracts. Further, each customer receives an individual price list.

Some of our products did not see an increase in price during 2020 as we were already price leaders. Overall, however, our ratio of weighted average rate of net price increases for our products to the annual increase in the U.S. Consumer Price Index during 2020 was 0.7% : 1.4%.