Clearance Summary
KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS received FDA 510(k) clearance under submission number K961381, sponsored by The Emerging Technologies Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-09-09.
- Submission: K961381
- Applicant / Sponsor: The Emerging Technologies Group
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1997-09-09
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.