Cleared Traditional

K254091 - GLOSSY COAT (15ML)

K254091 is an FDA 510(k) clearance for GLOSSY COAT (15ML), manufactured by YAMAHACHI DENTAL MFG., Co.. The device is a Class 2 Dental device with product code EBD cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K254091 · YAMAHACHI DENTAL MFG., Co. · Dental device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K254091

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.

EBD Device Classification - Class 2, Special Controls

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.

Regulatory Peers - EBD Coating, Filling Material, Resin

All 38
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