Clearance Summary
THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010 received FDA 510(k) clearance under submission number K983535, sponsored by Hans Hermann GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1998-12-29.
- Submission: K983535
- Applicant / Sponsor: Hans Hermann GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 1998-12-29
Classification & Regulation
This clearance is catalogued under FDA product code JEY and 21 CFR 872.4760, within the Dental review panel as a Class II device.