Cleared Traditional

K254112 - Dia-X Sil Bite

K254112 is an FDA 510(k) clearance for Dia-X Sil Bite, manufactured by DiaDent Group International. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K254112 · DiaDent Group International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
90d
Days
Class 2
Risk

K254112 is an FDA 510(k) clearance for the Dia-X Sil Bite. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by DiaDent Group International (Cheongju-Si, KR). The FDA issued a Cleared decision on March 19, 2026 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 - K254112

510(k) Number K254112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2025
Decision Date March 19, 2026
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 195
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K254112.
Hydro Print Premium Fast Set - 454g (1lb) (052037)
K253501 · Vigodent Ind?stria E Comercio Ltda · Oct 2025
JET BITE
K250969 · Dent4you AG · Jun 2025
Elastic Impression Material
K241924 · Beijing Okvd Biological Technology , Ltd. · Dec 2024
Speedex Light Body
K242360 · Dent4you AG · Nov 2024
Chemi-SiL (HB, MB, LB, LBS)
K233954 · B&E Korea Co., Ltd. · Feb 2024
DentMix VPS Impression Material
K223892 · Innovative Product Brands, Inc. · Apr 2023