Clearance Summary
DETAX IMPLANTLINK SEMI received FDA 510(k) clearance under submission number K100247, sponsored by Detax GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2010-07-23.
- Submission: K100247
- Applicant / Sponsor: Detax GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2010-07-23
Classification & Regulation
This clearance is catalogued under FDA product code EMA and 21 CFR 872.3275, within the Dental review panel as a Class II device.