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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Dreve Dentamid GmbH. It received FDA 510(k) clearance on 2018-04-13 under 510(k) 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. The listed applicant is Dreve Dentamid GmbH. The 510(k) number is K171562.

When did Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono receive FDA 510(k) clearance?

Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono received FDA 510(k) clearance on 2018-04-13, under 510(k) number K171562.

Who is the listed applicant for Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono?

The FDA 510(k) record lists Dreve Dentamid GmbH as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07586163Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse DeficiencyACTIVE_NOT_RECRUITING

Other records listing Dreve Dentamid GmbH as applicant

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Related Devices (Code: ELW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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