Clearance Summary
OCO DENTAL IMPLANT received FDA 510(k) clearance under submission number K021460, sponsored by O Co., Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-05-22.
- Submission: K021460
- Applicant / Sponsor: O Co., Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2002-05-22
Classification & Regulation
This clearance is catalogued under FDA product code NHA and 21 CFR 872.3630, within the Dental review panel as a Class II device.