Clearance Summary
IMPLASA-HOECHST GMBH IMPLANTS received FDA 510(k) clearance under submission number K071240, sponsored by Implasa-Hoechst 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 2008-01-24.
- Submission: K071240
- Applicant / Sponsor: Implasa-Hoechst GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2008-01-24
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.