Cleared Traditional

DiaFil Flow (K192284) - FDA 510(k) Clearance

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

K192284 · DiaDent Group International · Dental device
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Mar 2020
Decision
216d
Days
Class 2
Risk

K192284 is an FDA 510(k) clearance for the DiaFil Flow. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by DiaDent Group International (Cheongju-Si, KR). The FDA issued a Cleared decision on March 25, 2020 after a review of 216 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 K192284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2019
Decision Date March 25, 2020
Days to Decision 216 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
89d slower than avg
Panel avg: 127d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 291
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K192284.
CharmFil
K193496 · Dentkist, Inc. · May 2020
Zircos-Com
K190139 · Bioden Co., Ltd. · Apr 2020
GrandioSO Light Flow
K200294 · Voco GmbH · Mar 2020
DIAFIL & DIAFIL Capsule
K192510 · DiaDent Group International · Mar 2020
Ezfil
K191991 · Meta Biomed Co., Ltd. · Mar 2020
Allcem Veneer APS
K191389 · Dentscare Ltda · Feb 2020