Cleared Traditional

COMFORTSOFT SOFT DENTURE LINER SYSTEM

K140146 · Whip-Mix Corp. · Dental
Apr 2014
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K140146 is an FDA 510(k) clearance for the COMFORTSOFT SOFT DENTURE LINER SYSTEM, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Whip-Mix Corp. (Louisville, US). The FDA issued a Cleared decision on April 29, 2014, 97 days after receiving the submission on January 22, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K140146 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2014
Decision Date April 29, 2014
Days to Decision 97 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBI — Resin, Denture, Relining, Repairing, Rebasing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3760

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