Clearance Summary
FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE received FDA 510(k) clearance under submission number K855136, sponsored by Union Broach, Div. Moyco Industries, 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 1986-03-06.
- Submission: K855136
- Applicant / Sponsor: Union Broach, Div. Moyco Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1986-03-06
Classification & Regulation
This clearance is catalogued under FDA product code EKS and 21 CFR 872.4565, within the Dental review panel as a Class I device.