Cleared Traditional

K131504 - UNIVERSAL OPAQUE

K131504 is an FDA 510(k) clearance for UNIVERSAL OPAQUE, manufactured by Shofu Dental Corporation. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K131504 · Shofu Dental Corporation · Dental device
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Jul 2013
Decision
53d
Days
Class 2
Risk

K131504 is an FDA 510(k) clearance for the UNIVERSAL OPAQUE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on July 16, 2013 after a review of 53 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shofu Dental Corporation devices

FDA 510(k) Submission Details - K131504

510(k) Number K131504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2013
Decision Date July 16, 2013
Days to Decision 53 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 127d · This submission: 53d
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 782
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K131504.
SHOFU BLOCK HC
K130841 · Shofu Dental Corporation · Sep 2013
OPTIFLOW II FLOWABLE COMPOSITE, LC
K130672 · Pac-Dent International, Inc. · Aug 2013
MFP-051
K123631 · GC America, Inc. · Jul 2013
INTERLIG
K123823 · Angelus Industria DE Productos Odontologicos · May 2013
CLEARFIL MAJESTY ES FLOW
K130371 · Kuraray Noritake Dental, Inc. · Apr 2013
DENTOCORE / DENTOCORE BODY
K121769 · Itena Clinical · Mar 2013