Clearance Summary
RACE ENDODONTIC FILE received FDA 510(k) clearance under submission number K002709, sponsored by Amc General, 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 2000-11-17.
- Submission: K002709
- Applicant / Sponsor: Amc General, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2000-11-17
Classification & Regulation
This clearance is catalogued under FDA product code EFA and 21 CFR 872.4200, within the Dental review panel as a Class I device.