# K060637: Denfil Flow

- Pathway: 510(k) (Traditional)
- Applicant: Vericom Co., Ltd.
- Decided: Mar 16, 2006 after 6 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 K993783 (1999). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993783: Tetric Flow, Ivoclar North America, Inc. (1999) Summary page 1.

## Most influential descendants
- K192284: DiaFil Flow (2020), 0 descendants of its own
- K140976: Enaden Flow (2014), 0 descendants of its own

## Indications for use
Class V restorations (cervical caries, root erosion, wedge shaped defects) Anterior restorations (Class DLI, IV) Small posterior restorations Restorative therapy for mini-cavities of all types Extended fissures sealings in molars and premolars Repair of composite/ceramic veneers Blocking out of undercuts

Source page: https://510kreport.com/device/K060637
Methodology: https://510kreport.com/methodology