Clearance Summary
TEMP. CROWN MSTERIAL FOR TEETH received FDA 510(k) clearance under submission number K781244, 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 1978-08-31.
- Submission: K781244
- Applicant / Sponsor: Den-Mat Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3770
- Decision date: 1978-08-31
Classification & Regulation
This clearance is catalogued under FDA product code EBG and 21 CFR 872.3770, within the Dental review panel as a Class II device.