Clearance Summary
HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE received FDA 510(k) clearance under submission number K080682, sponsored by Handpiece Headquarters, Inc. - Hpr, 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 2008-09-11.
- Submission: K080682
- Applicant / Sponsor: Handpiece Headquarters, Inc. - Hpr, Inc.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2008-09-11
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.