Cleared Traditional

AIM2

K181011 · GC America, Inc. · Dental
Jul 2018
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K181011 is an FDA 510(k) clearance for the AIM2, a Material, Impression (Class II — Special Controls, product code ELW), submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on July 12, 2018, 86 days after receiving the submission on April 17, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K181011 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2018
Decision Date July 12, 2018
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

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