# K993973: Fuji II LC Capsule

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jan 11, 2000 after 49 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 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
- K052235: LCR (2005), 6 descendants of its own
- 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

## Indications for use
a. Class III and V restorations; particularly areas of cervical erosion, abfraction lesions and root surface caries. b. Restoration of primary teeth c. As a base or liner d. Core build-ups/block-outs (particularly of vital teeth) e. Cases in which a radiopaque restoration is required

Source page: https://510kreport.com/device/K993973
Methodology: https://510kreport.com/methodology