Cleared Traditional

K152927 - BRILLIANT EVERGLOW

K152927 is the FDA 510(k) clearance for BRILLIANT EVERGLOW by Coltene/Whaledent AG. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K152927 · Coltene/Whaledent AG · Dental device
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Apr 2016
Decision
206d
Days
Class 2
Risk

K152927 is an FDA 510(k) clearance for the BRILLIANT EVERGLOW. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Coltene/Whaledent AG (Altstatten, CH). The FDA issued a Cleared decision on April 28, 2016 after a review of 206 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 Coltene/Whaledent AG devices

Submission Details

510(k) Number K152927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2015
Decision Date April 28, 2016
Days to Decision 206 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 127d · This submission: 206d
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 517
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K152927.
Gradia Plus
K153325 · GC America, Inc. · Jul 2016
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
BEAUTIFIL II Enamel
K151699 · Shofu Dental Corporation · Dec 2015
Admira Fusion x-tra
K151956 · Voco GmbH · Oct 2015