Cleared Traditional

K173500 - NMF004A

K173500 is an FDA 510(k) clearance for NMF004A, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K173500 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
115d
Days
Class 2
Risk

K173500 is an FDA 510(k) clearance for the NMF004A. 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 March 8, 2018 after a review of 115 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

FDA 510(k) Submission Details - K173500

510(k) Number K173500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2017
Decision Date March 08, 2018
Days to Decision 115 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
12d faster than avg
Panel avg: 127d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

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 684
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K173500.
Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue
K181484 · Zirkonzahn Srl · Jun 2018
BeautiCem Veneer Kit
K180649 · Shofu Dental Corporation · Jun 2018
Tetric CAD
K173573 · Ivoclar Vivadent, AG · Jun 2018
OMNICHROMA
K173275 · Tokuyama Dental Corporation · Feb 2018
Trilor Disks, Blocks and Arches
K173643 · Bioloren S.R.L. · Feb 2018
Ecosite Bulk Fill
K171772 · Dmg USA, Inc. · Jan 2018