Clearance Summary
W-H TOPAIR DENTAL HANDPIECE received FDA 510(k) clearance under submission number K912786, sponsored by Sabra-The Dental Products Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-07-17.
- Submission: K912786
- Applicant / Sponsor: Sabra-The Dental Products Group
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1991-07-17
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.