Cleared Traditional

WHIP MIX PREPPIES PLUS

K131760 · Whip-Mix Corp. · Dental
Mar 2014
Decision
282d
Days
Class 1
Risk

About This 510(k) Submission

K131760 is an FDA 510(k) clearance for the WHIP MIX PREPPIES PLUS, a Agent, Polishing, Abrasive, Oral Cavity (Class I — General Controls, product code EJR), submitted by Whip-Mix Corp. (Louisville, US). The FDA issued a Cleared decision on March 26, 2014, 282 days after receiving the submission on June 17, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.6030.

Submission Details

510(k) Number K131760 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2013
Decision Date March 26, 2014
Days to Decision 282 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EJR — Agent, Polishing, Abrasive, Oral Cavity
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6030

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