Clearance Summary
PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE received FDA 510(k) clearance under submission number K870797, sponsored by Safco Dental Supply. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1987-05-01.
- Submission: K870797
- Applicant / Sponsor: Safco Dental Supply
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1987-05-01
Classification & Regulation
This clearance is catalogued under FDA product code EKX and 21 CFR 872.4200, within the Dental review panel as a Class I device.