Cleared Traditional

K192510 - DIAFIL & DIAFIL Capsule

K192510 is an FDA 510(k) clearance for DIAFIL & DIAFIL Capsule, manufactured by DiaDent Group International. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K192510 · DiaDent Group International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
190d
Days
Class 2
Risk

K192510 is an FDA 510(k) clearance for the DIAFIL & DIAFIL Capsule. 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 20, 2020 after a review of 190 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

FDA 510(k) Submission Details - K192510

510(k) Number K192510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2019
Decision Date March 20, 2020
Days to Decision 190 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
63d slower than avg
Panel avg: 127d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

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 648
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K192510.
Zircos-Com
K190139 · Bioden Co., Ltd. · Apr 2020
GrandioSO Light Flow
K200294 · Voco GmbH · Mar 2020
DiaFil Flow
K192284 · DiaDent Group International · Mar 2020
Ezfil
K191991 · Meta Biomed Co., Ltd. · Mar 2020
Allcem Veneer APS
K191389 · Dentscare Ltda · Feb 2020
R&D Series Nova Compo N
K192178 · Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · Dec 2019