Clearance Summary
OPTIMUS CMF SYSTEM received FDA 510(k) clearance under submission number K140037, sponsored by Osteonic Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2015-01-20.
- Submission: K140037
- Applicant / Sponsor: Osteonic Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2015-01-20
Classification & Regulation
This clearance is catalogued under FDA product code JEY and 21 CFR 872.4760, within the Dental review panel as a Class II device.