Clearance Summary
REVENEER CERAMIC REPAIR SYSTEM received FDA 510(k) clearance under submission number K052189, sponsored by Schutz-Dental GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2005-10-17.
- Submission: K052189
- Applicant / Sponsor: Schutz-Dental GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3200
- Decision date: 2005-10-17
Classification & Regulation
This clearance is catalogued under FDA product code KLE and 21 CFR 872.3200, within the Dental review panel as a Class II device.