Cleared Traditional

DiaTemp Flow (K192022) - FDA 510(k) Clearance

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

K192022 · DiaDent Group International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
199d
Days
Class 2
Risk

K192022 is an FDA 510(k) clearance for the DiaTemp Flow. 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 199 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

Submission Details

510(k) Number K192022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2019
Decision Date February 13, 2020
Days to Decision 199 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
72d slower than avg
Panel avg: 127d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 62
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K192022.
ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA
K200676 · Zirkonzahn Srl · Jul 2020
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
K192158 · DiaDent Group International · Feb 2020
DENTCA Crown and Bridge
K192806 · Dentca, Inc. · Feb 2020
Portux CAD/CAM Disc
K192153 · New Stetic, SA · Nov 2019