Clearance Summary
A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT received FDA 510(k) clearance under submission number K082827, sponsored by A-Dec, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-01-07.
- Submission: K082827
- Applicant / Sponsor: A-Dec, Inc.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2009-01-07
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.