# K091388: GCUC-505

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jul 22, 2009 after 72 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
Longest line of descent: 1 generation back to K042819 (2004). 3 ancestors in all.
43 later devices descend from it; 6 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042348: Gradia Direct Loflo, GC America, Inc. (2004) Summary page 1.
- K082434: GDLS-200, GC America, Inc. (2008) Summary page 1.
- K042819: Tetric Evoceram, Ivoclar Vivadent, Inc. (2004) Summary page 1.

## Most influential descendants
- K123631: MFP-051 (2013), 39 descendants of its own
- K133824: Cerasmart (2014), 32 descendants of its own
- K160425: CAD/CAMouflage Milling Bock (2016), 26 descendants of its own
- K162537: CAD/CAMouflage Milling Block (2016), 25 descendants of its own
- K201668: VarseoSmile Crown plus (2020), 24 descendants of its own

## Indications for use
Restoration of Class I, il, III, IV, V cavities Restoration of root surface caries Restorations in deciduous teeth Filling tunnel shaped cavities Sealing hypersensitive areas Liner/base/filling in cavity undercuts Sealant Splinting mobile teeth Additions to composite restorations

Source page: https://510kreport.com/device/K091388
Methodology: https://510kreport.com/methodology