# K120521: GC Blue Silicone

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: May 10, 2012 after 79 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: 3 generations back to K955932 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110871: Fit Checker Advanced, GC America, Inc. (2011) Summary page 1.
- K032289: Fit Checker II, GC America, Inc. (2003) Summary page 1.
- K041398: GC Fusion, GC America, Inc. (2004) Summary page 1.

## Indications for use
GC BLUE SILICONE is a silicone impression material for fit check by detecting the high spots and pressure points of ceramic crowns, ceramic bridges, ceramic inlays and the occlusal surface.

Source page: https://510kreport.com/device/K120521
Methodology: https://510kreport.com/methodology