# K041398: GC Fusion

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jun 25, 2004 after 30 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; 3 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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K110871: Fit Checker Advanced (2011), 1 descendant of its own
- K092867: Identium Heavy, Medium, Medium Soft, Light (2009), 1 descendant of its own
- K120521: GC Blue Silicone (2012), 0 descendants of its own
- K113279: Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium Scan Light (2011), 0 descendants of its own

## Indications for use
The Product is a dental vinylpolysiloxane impression material intended for use of taking intra-oral impressions of a patient's mouth.

Source page: https://510kreport.com/device/K041398
Methodology: https://510kreport.com/methodology