Cleared Traditional

CeraClean

K163171 · Bisco, Inc. · Dental
Apr 2017
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K163171 is an FDA 510(k) clearance for the CeraClean, a External Cleaning Solution (Class II — Special Controls, product code PME), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on April 14, 2017, 151 days after receiving the submission on November 14, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number K163171 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2016
Decision Date April 14, 2017
Days to Decision 151 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code PME — External Cleaning Solution
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3260
Definition For Use On Dental Restorations, External To The Mouth, Prior To Insertion Into The Mouth.