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FDA 510(k)

DD cube ONE ML

K-Number: K183569 · 2019-02-14

Decision Date2019-02-14
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DD cube ONE ML 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 2019-02-14 under 510(k) number K183569. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DD cube ONE ML?

DD cube ONE ML is a medical device that received FDA 510(k) clearance on 2019-02-14. The listed applicant is Dental Direkt GmbH. The 510(k) number is K183569.

When did DD cube ONE ML receive FDA 510(k) clearance?

DD cube ONE ML received FDA 510(k) clearance on 2019-02-14, under 510(k) number K183569.

Who is the listed applicant for DD cube ONE ML?

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 cube ONE ML?

The FDA product code for DD cube ONE ML is EIH.

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: EIH)

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

View on FDA Database →

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