Clearance Summary
Hyflex Heavy, Hyflex Mono, Hyflex Light received FDA 510(k) clearance under submission number K151262, sponsored by Osstem Implant 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 2015-09-21.
- Submission: K151262
- Applicant / Sponsor: Osstem Implant Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 2015-09-21
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.