Clearance Summary
DEN-MAT CERINATE PORCELAIN received FDA 510(k) clearance under submission number K895731, sponsored by Den-Mat Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1990-08-03.
- Submission: K895731
- Applicant / Sponsor: Den-Mat Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 1990-08-03
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.