Cleared Traditional

K181011 - AIM2 (FDA 510(k) Clearance)

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

K181011 is an FDA 510(k) clearance for the AIM2. This device is classified as 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 FDA review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K181011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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