Cleared Special

K150196 - DD cubeX2

K150196 is an FDA 510(k) clearance for DD cubeX2, manufactured by Dental Direkt GmbH. The device is a Class 2 Dental device with product code EIH cleared through the Special 510(k) pathway after a 56-day FDA review.

K150196 · Dental Direkt GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
56d
Days
Class 2
Risk

K150196 is an FDA 510(k) clearance for the DD cubeX2. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dental Direkt GmbH (Spenge, DE). The FDA issued a Cleared decision on March 26, 2015 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dental Direkt GmbH devices

FDA 510(k) Submission Details - K150196

510(k) Number K150196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2015
Decision Date March 26, 2015
Days to Decision 56 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 128d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EIH Powder, Porcelain

All 468
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