Clearance Summary
(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE received FDA 510(k) clearance under submission number K901552, sponsored by Nobelpharma USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-06-24.
- Submission: K901552
- Applicant / Sponsor: Nobelpharma USA, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3710
- Decision date: 1991-06-24
Classification & Regulation
This clearance is catalogued under FDA product code EJH and 21 CFR 872.3710, within the Dental review panel as a Class II device.