Clearance Summary
Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono received FDA 510(k) clearance under submission number K171562, sponsored by Dreve Dentamid GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2018-04-13.
- Submission: K171562
- Applicant / Sponsor: Dreve Dentamid GmbH
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 2018-04-13
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.