Clearance Summary
Zeramex P6 Dental Implant System received FDA 510(k) clearance under submission number K163043, sponsored by Dentalpoint AG. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2016-11-30.
- Submission: K163043
- Applicant / Sponsor: Dentalpoint AG
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2016-11-30
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.