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FDA 510(k)

DD medical polymers

K-Number: K153490 · 2016-05-13

Decision Date2016-05-13
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DD medical polymers is the device name listed in this FDA 510(k) record. The listed applicant is Dental Direkt GmbH. It received FDA 510(k) clearance on 2016-05-13 under 510(k) number K153490. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DD medical polymers?

DD medical polymers is a medical device that received FDA 510(k) clearance on 2016-05-13. The listed applicant is Dental Direkt GmbH. The 510(k) number is K153490.

When did DD medical polymers receive FDA 510(k) clearance?

DD medical polymers received FDA 510(k) clearance on 2016-05-13, under 510(k) number K153490.

Who is the listed applicant for DD medical polymers?

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

What is the FDA product code for DD medical polymers?

The FDA product code for DD medical polymers is EBG.

Other records listing Dental Direkt GmbH as applicant

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.

View all 8 devices →

Related Devices (Code: EBG)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.