Clearance Summary
OPULENT 76 AND 83 received FDA 510(k) clearance under submission number K945723, sponsored by Aalba Dent, 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 1994-12-29.
- Submission: K945723
- Applicant / Sponsor: Aalba Dent, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3060
- Decision date: 1994-12-29
Classification & Regulation
This clearance is catalogued under FDA product code EJT and 21 CFR 872.3060, within the Dental review panel as a Class II device.