DD cube ONE ML
K-Number: K183569 · 2019-02-14
ApplicantDental Direkt GmbH
Decision Date2019-02-14
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
DD cube ONE ML is a medical device manufactured by Dental Direkt GmbH. It received FDA 510(k) clearance on 2019-02-14 under approval 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. It is manufactured by Dental Direkt GmbH. The 510(k) number is K183569.
When was DD cube ONE ML approved by the FDA?
DD cube ONE ML received FDA 510(k) clearance on 2019-02-14, under approval number K183569.
What company makes DD cube ONE ML?
DD cube ONE ML is manufactured by Dental Direkt GmbH.
What is the FDA product code for DD cube ONE ML?
The FDA product code for DD cube ONE ML is EIH.
Other Devices by Dental Direkt GmbH
Related Devices (Code: EIH)
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.