Cleared Traditional

K132141 - BEAUTIFIL BULK FLOWABLE

K132141 is the FDA 510(k) clearance for BEAUTIFIL BULK FLOWABLE by Shofu Dental Corporation. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K132141 · Shofu Dental Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
84d
Days
Class 2
Risk

K132141 is an FDA 510(k) clearance for the BEAUTIFIL BULK FLOWABLE. 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 October 3, 2013 after a review of 84 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

Submission Details

510(k) Number K132141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2013
Decision Date October 03, 2013
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
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 515
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K132141.
HTFX-222
K133182 · GC America, Inc. · Apr 2014
CERASMART
K133824 · GC America, Inc. · Mar 2014
BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK
K132748 · Shofu Dental Corporation · Dec 2013
SHOFU BLOCK HC
K130841 · Shofu Dental Corporation · Sep 2013
MFP-051
K123631 · GC America, Inc. · Jul 2013
UNIVERSAL OPAQUE
K131504 · Shofu Dental Corporation · Jul 2013