Clearance Summary
GENESIS IMPLANT SYSTEM received FDA 510(k) clearance under submission number K101545, sponsored by Keystone Dental. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2010-10-28.
- Submission: K101545
- Applicant / Sponsor: Keystone Dental
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2010-10-28
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.