Clearance Summary
DENTAL ROOT ELEVATOR received FDA 510(k) clearance under submission number K892255, sponsored by Zinnanti Surgical Instruments, 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 1989-05-01.
- Submission: K892255
- Applicant / Sponsor: Zinnanti Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3600
- Decision date: 1989-05-01
Classification & Regulation
This clearance is catalogued under FDA product code EKO and 21 CFR 872.3600, within the Dental review panel as a Class II device.