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FDA 510(k)

DD cubeX2 HS

K-Number: K170885 · 2017-08-01

Decision Date2017-08-01
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DD cubeX2 HS is a medical device manufactured by Dental Direkt GmbH. It received FDA 510(k) clearance on 2017-08-01 under approval number K170885. 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 cubeX2 HS?

DD cubeX2 HS is a medical device that received FDA 510(k) clearance on 2017-08-01. It is manufactured by Dental Direkt GmbH. The 510(k) number is K170885.

When was DD cubeX2 HS approved by the FDA?

DD cubeX2 HS received FDA 510(k) clearance on 2017-08-01, under approval number K170885.

What company makes DD cubeX2 HS?

DD cubeX2 HS is manufactured by Dental Direkt GmbH.

What is the FDA product code for DD cubeX2 HS?

The FDA product code for DD cubeX2 HS is EIH.

Other Devices by Dental Direkt GmbH

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Related Devices (Code: EIH)

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.