Clearance Summary
SM-EXTRA WIDE (RBM) IMPLANT SYSTEM received FDA 510(k) clearance under submission number K080128, sponsored by Dio Department Dsi, 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 2008-05-14.
- Submission: K080128
- Applicant / Sponsor: Dio Department Dsi, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2008-05-14
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.