Clearance Summary
M4 CONTRA-ANGLE HANDPIECE received FDA 510(k) clearance under submission number K942480, sponsored by Kerr Corporation (Danbury). The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-01-27.
- Submission: K942480
- Applicant / Sponsor: Kerr Corporation (Danbury)
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1995-01-27
Classification & Regulation
This clearance is catalogued under FDA product code EGS and 21 CFR 872.4200, within the Dental review panel as a Class I device.