Clearance Summary
ROOT CANAL FILES & REAMERS received FDA 510(k) clearance under submission number K770367, sponsored by Cemco Tool Co., 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 1977-03-01.
- Submission: K770367
- Applicant / Sponsor: Cemco Tool Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1977-03-01
Classification & Regulation
This clearance is catalogued under FDA product code EKP and 21 CFR 872.4565, within the Dental review panel as a Class I device.