Clearance Summary
ALPHA-DENT COPAL CAVITY VARNISH received FDA 510(k) clearance under submission number K955521, sponsored by Wallace A. Erickson & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1996-01-24.
- Submission: K955521
- Applicant / Sponsor: Wallace A. Erickson & Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3260
- Decision date: 1996-01-24
Classification & Regulation
This clearance is catalogued under FDA product code LBH and 21 CFR 872.3260, within the Dental review panel as a Class II device.