# K042348: Gradia Direct Loflo

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Nov 18, 2004 after 80 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.
44 later devices descend from it; 1 cites it directly.
0 of 45 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
- K091388: GCUC-505 (2009), 43 descendants of its own
- 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

## Indications for use
This product is a light-cured fluoride releasing micro-filled hybrid composite restorative resin. Recommended Indications: 1. Restoration of Class I, II, III, IV, V cavities (particularly for small Class I cavities/ shallow Class V cavities/ other small cavities). 2. Restoration of root surface caries. 3. Restorations in deciduous teeth. 4. Filling tunnel shaped cavities. 5. Sealing hypersensitive areas. 6. Liner/base/filling in cavity under-cuts. 7. Sealant 8. Fixation of mobile teeth. 9. Additions to composite restoraions

Source page: https://510kreport.com/device/K042348
Methodology: https://510kreport.com/methodology