Clearance Summary
J2A Dental Implant System, J2C Dental Implant System received FDA 510(k) clearance under submission number K150060, sponsored by Kj Meditech Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2015-04-02.
- Submission: K150060
- Applicant / Sponsor: Kj Meditech Co., Ltd.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2015-04-02
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.