Clearance Summary
DEN-MAT PAINT-ON RUBBER DAM received FDA 510(k) clearance under submission number K852630, 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 1985-12-18.
- Submission: K852630
- Applicant / Sponsor: Den-Mat Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6300
- Decision date: 1985-12-18
Classification & Regulation
This clearance is catalogued under FDA product code EIE and 21 CFR 872.6300, within the Dental review panel as a Class I device.