Clearance Summary
STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 received FDA 510(k) clearance under submission number K053643, sponsored by Lifecore Biomedical, 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 2006-01-23.
- Submission: K053643
- Applicant / Sponsor: Lifecore Biomedical, Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2006-01-23
Classification & Regulation
This clearance is catalogued under FDA product code NHA and 21 CFR 872.3630, within the Dental review panel as a Class II device.