Clearance Summary
ALPHA-BOND DENTIN BONDING SYSTEM received FDA 510(k) clearance under submission number K954177, sponsored by Alpha-Bond, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-09-27.
- Submission: K954177
- Applicant / Sponsor: Alpha-Bond, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 1995-09-27
Classification & Regulation
This clearance is catalogued under FDA product code EMA and 21 CFR 872.3275, within the Dental review panel as a Class II device.