Cleared Traditional

K254091 - GLOSSY COAT (15ML) (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K254091 · YAMAHACHI DENTAL MFG., Co. · Dental device
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Optimized for regulatory review, auditing and printing
Apr 2026
Decision
108d
Days
Class 2
Risk

K254091 is an FDA 510(k) clearance for the GLOSSY COAT (15ML). Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by YAMAHACHI DENTAL MFG., Co. (Gamagori, JP). The FDA issued a Cleared decision on April 6, 2026 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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 YAMAHACHI DENTAL MFG., Co. devices

Submission Details

510(k) Number K254091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2025
Decision Date April 06, 2026
Days to Decision 108 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
19d faster than avg
Panel avg: 127d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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.