Cleared Traditional

K151541 - G-Fix

K151541 is the FDA 510(k) clearance for G-Fix by GC America, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K151541 · GC America, Inc. · Dental device
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Oct 2015
Decision
123d
Days
Class 2
Risk

K151541 is an FDA 510(k) clearance for the G-Fix. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on October 9, 2015 after a review of 123 days - within the typical 510(k) review window.

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: 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 GC America, Inc. devices

Submission Details

510(k) Number K151541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2015
Decision Date October 09, 2015
Days to Decision 123 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
4d faster than avg
Panel avg: 127d · This submission: 123d
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 424
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K151541.
Admira Fusion Flow
K153177 · Voco GmbH · Jun 2016
everX Posterior
K153127 · GC America, Inc. · May 2016
Admira Fusion x-tra
K151956 · Voco GmbH · Oct 2015
Mosaic Universal Composite
K151094 · Ultradent Products, Inc. · Jul 2015
Admira Fusion
K150784 · Voco GmbH · Jul 2015
HTFX-222
K133182 · GC America, Inc. · Apr 2014