Cleared Traditional

K151699 - BEAUTIFIL II Enamel

K151699 is the FDA 510(k) clearance for BEAUTIFIL II Enamel by Shofu Dental Corporation. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K151699 · Shofu Dental Corporation · Dental device
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Dec 2015
Decision
169d
Days
Class 2
Risk

K151699 is an FDA 510(k) clearance for the BEAUTIFIL II Enamel. 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 December 10, 2015 after a review of 169 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 Shofu Dental Corporation devices

Submission Details

510(k) Number K151699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2015
Decision Date December 10, 2015
Days to Decision 169 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
42d slower than avg
Panel avg: 127d · This submission: 169d
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 K151699.
Admira Fusion Flow
K153177 · Voco GmbH · Jun 2016
everX Posterior
K153127 · GC America, Inc. · May 2016
BEAUTIFIL II Gingiva
K151700 · Shofu Dental Corporation · Mar 2016
Admira Fusion x-tra
K151956 · Voco GmbH · Oct 2015
G-Fix
K151541 · GC America, Inc. · Oct 2015
Mosaic Universal Composite
K151094 · Ultradent Products, Inc. · Jul 2015