Clearance Summary
A-DEC 2182 DOCTOR'S UNIT received FDA 510(k) clearance under submission number K925319, sponsored by A-Dec, 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 1993-12-09.
- Submission: K925319
- Applicant / Sponsor: A-Dec, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6250
- Decision date: 1993-12-09
Classification & Regulation
This clearance is catalogued under FDA product code KLC and 21 CFR 872.6250, within the Dental review panel as a Class I device.