# K973343: Hydroflex

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Oct 21, 1997 after 46 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.
2 later devices descend from it; 1 cites it directly.
0 of 4 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.

## Most influential descendants
- K110871: Fit Checker Advanced (2011), 1 descendant of its own
- K120521: GC Blue Silicone (2012), 0 descendants of its own

## Indications for use
Hydroflex is intended to be used for taking intra-oral impressions of a person’s dentition

Source page: https://510kreport.com/device/K973343
Methodology: https://510kreport.com/methodology