# K181011: AIM2

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jul 12, 2018 after 86 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955932 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955932: Exaflex Impression Material (Modification), GC America, Inc. (1996) Summary page 4.

## Indications for use
AIM2 is a silicone impression material for taking oral impressions.

Source page: https://510kreport.com/device/K181011
Methodology: https://510kreport.com/methodology