Clearance Summary
Ti-one 101 TS Dental Implant System received FDA 510(k) clearance under submission number K172821, 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 2018-06-11.
- Submission: K172821
- 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: 2018-06-11
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.