Clearance Summary
TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG received FDA 510(k) clearance under submission number K001786, sponsored by Sulzer Calcitek, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-06-21.
- Submission: K001786
- Applicant / Sponsor: Sulzer Calcitek, Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2000-06-21
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.