Cleared Traditional

K192158 - DiaTemp

K192158 is an FDA 510(k) clearance for DiaTemp, manufactured by DiaDent Group International. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K192158 · DiaDent Group International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
188d
Days
Class 2
Risk

K192158 is an FDA 510(k) clearance for the DiaTemp. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by DiaDent Group International (Cheongju-Si, KR). The FDA issued a Cleared decision on February 13, 2020 after a review of 188 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 DiaDent Group International devices

FDA 510(k) Submission Details - K192158

510(k) Number K192158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2019
Decision Date February 13, 2020
Days to Decision 188 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
61d slower than avg
Panel avg: 127d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 112
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K192158.
VarseoSmile Temp
K193553 · Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG · May 2020
AA temp temporary restoration 3D printing photoreactive resin
K191590 · Enlighten Materials Co., Ltd. · May 2020
DiaTemp Flow
K192022 · DiaDent Group International · Feb 2020
DENTCA Crown and Bridge
K192806 · Dentca, Inc. · Feb 2020
Portux CAD/CAM Disc
K192153 · New Stetic, SA · Nov 2019
Ceramill A-Temp
K191843 · Amann Girrbach AG · Oct 2019