Clearance Summary
A.B. Dental Devices Dental Implants System received FDA 510(k) clearance under submission number K181381, sponsored by A.B. Dental Device , 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 2018-11-23.
- Submission: K181381
- Applicant / Sponsor: A.B. Dental Device , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2018-11-23
Classification & Regulation
This clearance is catalogued under FDA product code NHA and 21 CFR 872.3630, within the Dental review panel as a Class II device.