Clearance Summary
OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS received FDA 510(k) clearance under submission number K994435, sponsored by Jeneric/Pentron, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-02-10.
- Submission: K994435
- Applicant / Sponsor: Jeneric/Pentron, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2000-02-10
Classification & Regulation
This clearance is catalogued under FDA product code EIH and 21 CFR 872.6660, within the Dental review panel as a Class II device.