Cleared Traditional

AIM2 (K181011) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K181011 is an FDA 510(k) clearance for the AIM2. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on July 12, 2018 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all GC America, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 127d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 93
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K181011.
VPS Impression Material
K191034 · Hygedent, Inc. · Sep 2019
Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite
K181604 · Hrs Co., Ltd. · Nov 2018
HySil Impression Materials
K181236 · Osstem Implant Co., Ltd. · Sep 2018
PEAK NS033CF, PEAK NS017CF
K180565 · Neosil Co., Ltd. · Jun 2018
Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
K171562 · Dreve Dentamid GmbH · Apr 2018
GC BLUE SILICONE
K120521 · GC America, Inc. · May 2012