Nobel Biocare Receives FDA Clearance for the N1 Implant System

The United States Food and Drug Administration (FDA) has cleared the Nobel Biocare N1^™ implant system. The N1 is said to be a complete system for implants, including instruments, prosthetics, and surgical protocols. These instruments include the Osseoshaper^™, which shapes the osteotomy without irrigation and is designed to increase patient comfort and preserve bone.

This N1 implant system also includes Xeal^™ and TiUltra^™ treatments. These are abutments and implants respectively designed to make for easier tissue integration. These will be integrated into the DTX Studio^™ for a fully digital workflow. With federal 510(k) clearance, access to this implant system expands, reaching more patients, according to Patrik Eriksson, President Nobel Biocare.

"Drilling protocols have hardly changed over the past 50 years. However, the OsseoShaper™ provides a completely new approach designed for patient comfort, streamlined workflow, and improved predictability; while at the same time, respects biology to achieve fast osseointegration,” Eriksson said in a press release from the company. “We are excited to partner with clinicians to bring the N1 system to US-based patients."

With FDA clearance, Nobel Biocare hopes to bring the N1 Implant System to North American markets in the near future.