Clearance Summary
DUO-DENT DENTAL IMPLANT received FDA 510(k) clearance under submission number K010386, sponsored by Duo-Dent Dental Implant Systems, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2001-02-27.
- Submission: K010386
- Applicant / Sponsor: Duo-Dent Dental Implant Systems, LLC
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2001-02-27
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.