Clearance Summary
Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray received FDA 510(k) clearance under submission number K212932, sponsored by Nobel Biocare Services AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2021-12-18.
- Submission: K212932
- Applicant / Sponsor: Nobel Biocare Services AG
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2021-12-18
Classification & Regulation
This clearance is catalogued under FDA product code KCT and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.