Clearance Summary
STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR received FDA 510(k) clearance under submission number K863500, sponsored by Pacific Union Dental, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1986-09-22.
- Submission: K863500
- Applicant / Sponsor: Pacific Union Dental, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1986-09-22
Classification & Regulation
This clearance is catalogued under FDA product code EIS and 21 CFR 872.4565, within the Dental review panel as a Class I device.