Envista Gets FDA’s 510(k) Clearance for Its Nobel Biocare N1 Implant System

January 5, 2022

Envista has received the FDA’s 501(k) clearance for its the Nobel Biocare N1 implant system for use in osteotomy procedures.  

The N1 system includes dedicated instruments, prosthetic components and surgical protocols as well as the implant itself, according to the Brea, Calif.-based company.

The system also includes the OsseoShaper, a site preparation instrument designed to preserve vital bone.

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