Cleared Traditional

K261166 - DIA-CEM

K261166 is the FDA 510(k) clearance for DIA-CEM by DiaDent Group International. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K261166 · DiaDent Group International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
91d
Days
Class 2
Risk

K261166 is an FDA 510(k) clearance for the DIA-CEM. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by DiaDent Group International (Cheongju-Si, KR). The FDA issued a Cleared decision on July 9, 2026 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 K261166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2026
Decision Date July 09, 2026
Days to Decision 91 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 255
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K261166.
G-CEM UNIVERSAL
K254109 · GC America, Inc. · May 2026
REGEN Bioactive Cement
K253337 · Inter-Med, Inc. · Apr 2026
Bifix Veneer LC, Bifix Veneer Try-In
K252606 · Voco GmbH · Mar 2026
iCEM Universal Plus
K254063 · Kulzer, LLC · Dec 2025
TopCEM Vigor SA Self-Adhesive Resin Cement
K252785 · Rizhao Huge Biomaterials Company, Ltd. · Dec 2025
GlasIonomer FX-LC
K252808 · Shofu Dental Corporation · Dec 2025