Clearance Summary
Osteon Precision Milled Suprastructure received FDA 510(k) clearance under submission number K233083, sponsored by Implant Solutions Pty Ltd (Aka Osteon Medical). The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2024-03-09.
- Submission: K233083
- Applicant / Sponsor: Implant Solutions Pty Ltd (Aka Osteon Medical)
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2024-03-09
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.