Clearance Summary
FIXOBRIDGE 3-CEMENT received FDA 510(k) clearance under submission number K024287, sponsored by Advanced Healthcare , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2003-03-21.
- Submission: K024287
- Applicant / Sponsor: Advanced Healthcare , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2003-03-21
Classification & Regulation
This clearance is catalogued under FDA product code EMA and 21 CFR 872.3275, within the Dental review panel as a Class II device.