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.

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.

We have multiple programs in place to support product accessibility. We use a lower price list for our established product lines in low-income and lower-middle-income countries compared with developed markets. 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 2021 was 2.5% : 7.0%.2020 was 0.7% : 1.4%.