The Nobel Biocare N1 system includes OsseoShaper, an instrument for site preparation, which optimises workflows and reduces treatment times to deliver improved patient comfort
The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Envista, the holding entity of Nobel Biocare, announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the Nobel Biocare N1 implant system.
With a biologically driven design of components and advanced treatment protocols, the new system would deliver patient-centric implant solutions.
Beyond an implant, N1 is a complete system of dedicated instruments, prosthetics components, and surgical protocols, claimed the company.
The system comes with new features including an implant designed for immediate placement and predictable insertion torques.
It also includes a trioval conical connection for the abutment to slide into place, and an emergence profile designed for soft tissue maintenance.
Nobel Biocare president Patrik Eriksson said: “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.”
The Nobel Biocare N1 system also includes OsseoShaper, an instrument for site preparation, which optimises workflows, and reduces treatment times.
OsseoShaper is designed to gently shape the osteotomy at low speed, reduced noise and vibration, compared to conventional drilling protocols.
The N1 system is expected to deliver improved patient comfort and has shown to preserve vital bone in pre-clinical studies.
Also, the system features the Xeal and TiUltra surface treatments, with specially customised surface chemistry and topography to optimise tissue integration at every level.
Furthermore, Nobel Biocare N1 is expected to be further integrated into the digital workflow with the DTX Studio suite to provide patients with shorter time to teeth.
Envista is a holding entity of more than 30 trusted dental brands, including KaVo, Kerr, Nobel Biocare, and Ormco, among others.
Envista chief executive officer Amir Aghdaei said: “For over 50 years, Nobel Biocare has been a pioneering force behind implantology.
“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.”