Cleared Traditional

REVEAL Bulk

K171147 · Bisco, Inc. · Dental
Aug 2017
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K171147 is an FDA 510(k) clearance for the REVEAL Bulk, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on August 4, 2017, 107 days after receiving the submission on April 19, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K171147 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690