Clearance Summary
ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1 received FDA 510(k) clearance under submission number K964145, sponsored by Crystal Mark, 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 1996-12-31.
- Submission: K964145
- Applicant / Sponsor: Crystal Mark, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6080
- Decision date: 1996-12-31
Classification & Regulation
This clearance is catalogued under FDA product code KOJ and 21 CFR 872.6080, within the Dental review panel as a Class II device.