Clearance Summary
HC-BIOS DENTAL IMPLANT received FDA 510(k) clearance under submission number K110425, sponsored by Hung Chun Bio-S 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 2012-07-27.
- Submission: K110425
- Applicant / Sponsor: Hung Chun Bio-S Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2012-07-27
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.