Clearance Summary
IMPLANT-PROPHY & PLASTIC DENTAL INSTRUMENT SYSTEM received FDA 510(k) clearance under submission number K922779, sponsored by Advanced Implant Technologies, 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 1993-01-28.
- Submission: K922779
- Applicant / Sponsor: Advanced Implant Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1993-01-28
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.