Clearance Summary
PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT received FDA 510(k) clearance under submission number K860653, sponsored by Otc/America. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1986-04-17.
- Submission: K860653
- Applicant / Sponsor: Otc/America
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1986-04-17
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.