Cleared Traditional

K133182 - HTFX-222

K133182 is an FDA 510(k) clearance for HTFX-222, 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 174-day FDA review.

K133182 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
174d
Days
Class 2
Risk

K133182 is an FDA 510(k) clearance for the HTFX-222. 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 April 9, 2014 after a review of 174 days - an extended review cycle.

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 - K133182

510(k) Number K133182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date April 09, 2014
Days to Decision 174 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
47d slower than avg
Panel avg: 127d · This submission: 174d
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 710
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K133182.
Variolink Esthetic
K142389 · Ivoclar Vivadent, AG · Nov 2014
ABSOLUTE DENTIN 2
K132115 · Parkell, Inc. · Jun 2014
CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE)
K133850 · Prismatik Dentalcraft, Inc. · Jun 2014
CERASMART
K133824 · GC America, Inc. · Mar 2014
BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK
K132748 · Shofu Dental Corporation · Dec 2013
BEAUTIFIL BULK FLOWABLE
K132141 · Shofu Dental Corporation · Oct 2013