Clearance Summary
PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1 received FDA 510(k) clearance under submission number K101225, sponsored by Promimic AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2011-01-25.
- Submission: K101225
- Applicant / Sponsor: Promimic AB
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2011-01-25
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.