Cleared Abbreviated

Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono

K171562 · Dreve Dentamid GmbH · Dental
Apr 2018
Decision
318d
Days
Class 2
Risk

About This 510(k) Submission

K171562 is an FDA 510(k) clearance for the Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Dreve Dentamid GmbH (Unna, DE). The FDA issued a Cleared decision on April 13, 2018, 318 days after receiving the submission on May 30, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K171562 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2017
Decision Date April 13, 2018
Days to Decision 318 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

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