Clearance Summary
DEN-MAT DENTIN BONDING AGENT received FDA 510(k) clearance under submission number K801216, 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 1980-05-28.
- Submission: K801216
- Applicant / Sponsor: Den-Mat Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3200
- Decision date: 1980-05-28
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.