Cleared Traditional

K171147 - REVEAL Bulk

K171147 is an FDA 510(k) clearance for REVEAL Bulk, manufactured by Bisco, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K171147 · Bisco, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
107d
Days
Class 2
Risk

K171147 is an FDA 510(k) clearance for the REVEAL Bulk. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on August 4, 2017 after a review of 107 days - within the typical 510(k) review window.

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 Bisco, Inc. devices

FDA 510(k) Submission Details - K171147

510(k) Number K171147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2017
Decision Date August 04, 2017
Days to Decision 107 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
20d faster than avg
Panel avg: 127d · This submission: 107d
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 K171147.
Pekkton Ivory
K170102 · Cendres & Metaux SA · Nov 2017
Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl
K170873 · Swissmeditec GmbH · Oct 2017
Grandio blocs
K171200 · Voco GmbH · Aug 2017
Admira Fusion x-base
K170896 · Voco GmbH · Jun 2017
ESTELITE BULK FILL Flow
K161353 · Tokuyama Dental Corporation · Apr 2017
nuance UNIVERSAL
K162967 · Den-Mat Holdings, LLC · Mar 2017