Cleared Traditional

DD Contrast (K193588) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193588 · Dental Direkt GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
115d
Days
Class 2
Risk

K193588 is an FDA 510(k) clearance for the DD Contrast. 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 April 16, 2020 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dental Direkt GmbH devices

Submission Details

510(k) Number K193588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2019
Decision Date April 16, 2020
Days to Decision 115 days
Submission Type Traditional
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
12d faster than avg
Panel avg: 127d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - EIH Powder, Porcelain

All 184
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K193588.
Dental Zirconia Blocks
K192262 · De Corematrix Co., Ltd. · May 2020
VITA Ambria
K193436 · Vita Zahnfabrik GmbH H Rauter & CO · May 2020
Purzir Dental Zirconia
K193055 · 3DBiocad · May 2020
Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia
K192535 · Qinhuangdao Audental Metal Technology Co., Ltd. · Jan 2020
Noritake Super Porcelain EX-3
K193060 · Kuraray Noritake Dental, Inc. · Jan 2020
Livento Press, Soprano 10, Soprano
K192251 · Cendres & Metaux SA · Jan 2020