Clearance Summary
A-DEC/W&H ELECTRIC HANDPIECE MOTOR received FDA 510(k) clearance under submission number K133776, sponsored by A-Dec, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2014-05-28.
- Submission: K133776
- Applicant / Sponsor: A-Dec, Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2014-05-28
Classification & Regulation
This clearance is catalogued under FDA product code EBW and 21 CFR 872.4200, within the Dental review panel as a Class I device.