Clearance Summary
N1 TiUltra TCC Implant System received FDA 510(k) clearance under submission number K211109, sponsored by Nobel Biocare Services AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2021-12-21.
- Submission: K211109
- Applicant / Sponsor: Nobel Biocare Services AG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2021-12-21
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.