Clearance Summary
SOFT GRIP UNI-HANDLE received FDA 510(k) clearance under submission number K823913, sponsored by Treace Medical, 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 1983-01-26.
- Submission: K823913
- Applicant / Sponsor: Treace Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1983-01-26
Classification & Regulation
This clearance is catalogued under FDA product code EJB and 21 CFR 872.4565, within the Dental review panel as a Class I device.