Clearance Summary
IMPLANT CENTER received FDA 510(k) clearance under submission number K072030, sponsored by Satelec - Acteon Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2007-11-19.
- Submission: K072030
- Applicant / Sponsor: Satelec - Acteon Group
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4120
- Decision date: 2007-11-19
Classification & Regulation
This clearance is catalogued under FDA product code DZI and 21 CFR 872.4120, within the Dental review panel as a Class II device.