ZimVie US Corp LLC

ZimVie US Corp LLC specializes in dental osteotomes and powered surgical instruments. Their portfolio includes drills like the Driva™ and Dríva™ Gold Series, tapered screw-vent tools, reusable and sterile surgical dental instruments, and non-sterile dental instruments. They also produce Eztetic®, a product designed for specific dental procedures. These devices are tailored for surgical and dental applications.

ZimVie US Corp LLC is based in the United States. Since the company operates from the US, its devices may be subject to regulatory requirements under US laws, such as those governed by the FDA. Additionally, some of their devices are listed in the EU’s eudamed registry, indicating they may also comply with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) where applicable.

Some of ZimVie US Corp LLC’s devices are listed in the EU’s eudamed registry, which is a central database for medical devices authorized under EU regulations. This registry helps track devices that comply with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR). Listing in eudamed does not imply approval but confirms regulatory compliance for those specific devices.

The devices produced by ZimVie US Corp LLC fall under two main regulatory classifications: Class I and Class IIa. Class I devices are generally considered low-risk, such as some dental instruments, while Class IIa devices involve a higher level of risk and require additional scrutiny, like certain powered surgical instruments. Classification determines the regulatory pathway and requirements for authorization, such as conformity assessment procedures.