Cleared Traditional

K123631 - MFP-051

K123631 is an FDA 510(k) clearance for MFP-051, 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 242-day FDA review.

K123631 · GC America, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
242d
Days
Class 2
Risk

K123631 is an FDA 510(k) clearance for the MFP-051. 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 July 23, 2013 after a review of 242 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.

FDA 510(k) Submission Details - K123631

510(k) Number K123631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2012
Decision Date July 23, 2013
Days to Decision 242 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
114d slower than avg
Panel avg: 128d · This submission: 242d
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 878
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K123631.
BEAUTIFIL BULK FLOWABLE
K132141 · Shofu Dental Corporation · Oct 2013
SHOFU BLOCK HC
K130841 · Shofu Dental Corporation · Sep 2013
OPTIFLOW II FLOWABLE COMPOSITE, LC
K130672 · Pac-Dent International, Inc. · Aug 2013
UNIVERSAL OPAQUE
K131504 · Shofu Dental Corporation · Jul 2013
INTERLIG
K123823 · Angelus Industria DE Productos Odontologicos · May 2013
CLEARFIL MAJESTY ES FLOW
K130371 · Kuraray Noritake Dental, Inc. · Apr 2013
K123631 · MFP-051
Download PDF FDA Summary GC America, Inc.