Clearance Summary
DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHET received FDA 510(k) clearance under submission number K970572, sponsored by Implant Integration Systems, 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 1998-01-16.
- Submission: K970572
- Applicant / Sponsor: Implant Integration Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1998-01-16
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.