# K020117: GC Fuji Lining LC Paste Pak

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Feb 28, 2002 after 45 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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
- K123265: Rmgi Low Viscosity (2012), 5 descendants of its own
- K130223: Rmgi Fill (2013), 4 descendants of its own
- K153249: Pulpdent Solo Flowable Composite with MCP (2016), 1 descendant of its own
- K250953: Equia LC One (2025), 0 descendants of its own
- K210045: Activa Presto Pack (2021), 0 descendants of its own

## Indications for use
GC Fuji Lining LC Paste Pak is intended to be used as a base or liner in prepared cavities.

Source page: https://510kreport.com/device/K020117
Methodology: https://510kreport.com/methodology