Clearance Summary
TITANALOY SUBMERSIBLE IMPLANT SYSTEM received FDA 510(k) clearance under submission number K830414, sponsored by Boehringer/Miter, 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 1983-03-24.
- Submission: K830414
- Applicant / Sponsor: Boehringer/Miter, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1983-03-24
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.