Clearance Summary
A.B. DENTAL DEVICES Dental Implants System received FDA 510(k) clearance under submission number K162482, 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 2017-09-15.
- Submission: K162482
- Applicant / Sponsor: A.B. Dental Device , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2017-09-15
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.