Clearance Summary
ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS received FDA 510(k) clearance under submission number K133255, sponsored by Dentalpoint AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2014-08-12.
- Submission: K133255
- Applicant / Sponsor: Dentalpoint AG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2014-08-12
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.