Cleared Traditional

K261071 - DIAFIL Bulk FLOW (Economic Package)

Also marketed or referenced as:
DIAFIL Bulk FLOW (Refill Package) DIAFIL Bulk FLOW (0.5g)

K261071 is the FDA 510(k) clearance for DIAFIL Bulk FLOW (Economic Package) by DiaDent Group International. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K261071 · DiaDent Group International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
48d
Days
Class 2
Risk

K261071 is an FDA 510(k) clearance for the DIAFIL Bulk FLOW (Economic Package). 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 May 19, 2026 after a review of 48 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 K261071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2026
Decision Date May 19, 2026
Days to Decision 48 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
79d faster than avg
Panel avg: 127d · This submission: 48d
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 K261071.
Transcend Bulk Fill Flowable Composite
K262228 · Ultradent Products, Inc. · Jul 2026
SRGC-06
K261246 · GC America, Inc. · Jun 2026
DIAFIL
K261093 · DiaDent Group International · Jun 2026
Dual Core
K260805 · Vericom Co., Ltd. · May 2026
Dura-Crown
K261356 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Apr 2026
Grandio disc multicolor
K261357 · Voco GmbH · Apr 2026