# K955932: Exaflex Impression Material (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Mar 11, 1996 after 89 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K973343: Hydroflex (1997), 2 descendants of its own
- K110871: Fit Checker Advanced (2011), 1 descendant of its own
- K181011: AIM2 (2018), 0 descendants of its own
- K120521: GC Blue Silicone (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K955932
Methodology: https://510kreport.com/methodology