Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
FDA 510(k) K171562 · Dreve Dentamid GmbH
510(k) numberK171562
Submission
- Device name
- Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
- Applicant
- Dreve Dentamid GmbH
Unna, DE - Received
- May 30, 2017
- Decision date
- April 13, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono cleared by the FDA?
Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono (K171562) received a 510(k) decision of Substantially Equivalent on April 13, 2018, 318 days after the submission was received.
What is the product code of K171562?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.