Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono— 510(k) K171562

Name: FDA 510(k) clearance K171562
Creator: U.S. Food and Drug Administration
Published: 2018-04-13

Substantially Equivalent

Dreve Dentamid GmbH

FDA 510(k) clearance K171562 for Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono, Substantially Equivalent on 2018-04-13. Applicant: Dreve Dentamid GmbH. Device class: 2.

Clearance details

Applicant: Dreve Dentamid GmbH
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2017-05-30
Decision date: 2018-04-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Unna, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.