Clearance Summary
OPC LOWWEAR PORCELAIN received FDA 510(k) clearance under submission number K982377, 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 1998-08-18.
- Submission: K982377
- Applicant / Sponsor: Jeneric/Pentron, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 1998-08-18
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.