Clearance Summary
DIGITEK TITANIUM ABUTMENT received FDA 510(k) clearance under submission number K141970, sponsored by Digitek Dental Solutions Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2015-07-31.
- Submission: K141970
- Applicant / Sponsor: Digitek Dental Solutions Limited
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2015-07-31
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.