Clearance Summary
TI-BASE ABUTMENT, 1 CONNECT ABUTMENT received FDA 510(k) clearance under submission number K111935, sponsored by Nt-Trading GmbH and 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 2012-02-17.
- Submission: K111935
- Applicant / Sponsor: Nt-Trading GmbH and CO KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2012-02-17
Classification & Regulation
This clearance is catalogued under FDA product code NHA and 21 CFR 872.3630, within the Dental review panel as a Class II device.