Clearance Summary
RITE-ANGLE DISPOSABLE PROPHY ANGLES received FDA 510(k) clearance under submission number K954802, sponsored by Ash-USA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-11-08.
- Submission: K954802
- Applicant / Sponsor: Ash-USA
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1995-11-08
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.