Envista (NYSE:NVST) announced today that the FDA cleared the Nobel Biocare N1 implant system of instruments, prosthetic components and surgical protocols.
The N1 system includes an implant designed for immediate placement and predictable insertion torques, providing a trioval conical connection for the abutment to slide into place. Additionally, the system has an emergence profile designed for soft tissue maintenance.
It includes the OsseoShaper implant for redefining site preparation and reshaping implantology with optimized workflows, greater patient comfort and faster treatment times, according to a news release. The OsseoShaper “shapes” the osteotomy at a low speed and without irrigation to reduce noise and vibration compared to conventional drilling protocols.
“The demand for high-quality patient-centric solutions is higher than ever and the Nobel Biocare N1 system enables clinicians to set a new standard in personalizing, digitizing, and democratizing the implant treatment experience they can offer patients,” Envista CEO Amir Aghdaei said in the release.
Envista said the Nobel Biocare N1 features Xeal and TiUltra surface treatments to optimize tissue integration. The system will be further integrated into the digital workflow with the DTX Studio suite to give dental professionals more opportunities to provide patients with shorter time to teeth.
“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,” Nobel Biocare President Patirk Eriksson said. “We are excited to partner with clinicians to bring the N1 system to US-based patients.”