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DD cubeX2

by Dental Direkt GmbH

510(k) K150196

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK150196 Date26 Mar 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
EIH
Device class
Class II
Regulation
21 CFR Part 872.6660
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

DD cubeX2 is a dental zirconia device. It is a substantially equivalent product cleared through the FDA 510(k) process under product code EIH.

The device was manufactured by Dental Direkt GmbH in Spenge, Germany. It received FDA clearance on March 26, 2015, under K-number K150196, and is classified as a special clearance device reviewed by the Dental advisory committee.

Other devices from Dental Direkt GmbH

See all devices from Dental Direkt GmbH →

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the DD cubeX2 device used for?

    The DD cubeX2 is a dental zirconia device intended for use in dental applications, as indicated by its classification under product code EIH, which covers zirconia-based dental restorative materials.

  • How was the DD cubeX2 device cleared for market release?

    The DD cubeX2 received FDA clearance through the 510(k) process as a substantially equivalent product, with clearance granted on March 26, 2015, under K-number K150196, following review by the Dental advisory committee.

  • Who manufactures the DD cubeX2 and where is it produced?

    The DD cubeX2 is manufactured by Dental Direkt GmbH at their facility located at Industriezentrum 106-108, Spenge, Germany, with postal code 32139.