Clearance Summary
PALODENT MATRICES & BITINE RINGS received FDA 510(k) clearance under submission number K801142, sponsored by Alvin Meyer, D.D.S.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1980-08-07.
- Submission: K801142
- Applicant / Sponsor: Alvin Meyer, D.D.S.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1980-08-07
Classification & Regulation
This clearance is catalogued under FDA product code DZN and 21 CFR 872.4565, within the Dental review panel as a Class I device.