Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
K-Number: K171562 · 2018-04-13
ApplicantDreve Dentamid GmbH
Decision Date2018-04-13
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono is a medical device manufactured by Dreve Dentamid GmbH. It received FDA 510(k) clearance on 2018-04-13 under approval number K171562. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono?
Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono is a medical device that received FDA 510(k) clearance on 2018-04-13. It is manufactured by Dreve Dentamid GmbH. The 510(k) number is K171562.
When was Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono approved by the FDA?
Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono received FDA 510(k) clearance on 2018-04-13, under approval number K171562.
What company makes Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono?
Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono is manufactured by Dreve Dentamid GmbH.
What is the FDA product code for Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono?
The FDA product code for Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono is ELW.
Related Clinical Trials
Other Devices by Dreve Dentamid GmbH
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.