Cleared Special

K183569 - DD cube ONE ML (FDA 510(k) Clearance)

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K183569 · Dental Direkt GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
55d
Days
Class 2
Risk

K183569 is an FDA 510(k) clearance for the DD cube ONE ML. 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 February 14, 2019 after a review of 55 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

Submission Details

510(k) Number K183569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2018
Decision Date February 14, 2019
Days to Decision 55 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 127d · This submission: 55d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.

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All 478
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