Cleared Traditional

K261093 - DIAFIL

K261093 is the FDA 510(k) clearance for DIAFIL by DiaDent Group International. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K261093 · DiaDent Group International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
61d
Days
Class 2
Risk

K261093 is an FDA 510(k) clearance for the DIAFIL. 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 June 2, 2026 after a review of 61 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all DiaDent Group International devices

Submission Details

510(k) Number K261093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2026
Decision Date June 02, 2026
Days to Decision 61 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
66d faster than avg
Panel avg: 127d · This submission: 61d
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 516
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K261093.
Tetric plus Fill
K261485 · Ivoclar Vivadent, Inc. · Jul 2026
Transcend Bulk Fill Flowable Composite
K262228 · Ultradent Products, Inc. · Jul 2026
SRGC-06
K261246 · GC America, Inc. · Jun 2026
DIAFIL Bulk FLOW (Economic Package)
K261071 · DiaDent Group International · May 2026
Dual Core
K260805 · Vericom Co., Ltd. · May 2026
Dura-Crown
K261356 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Apr 2026