# K042124: Denfil

- Pathway: 510(k) (Traditional)
- Applicant: Vericom Co., Ltd.
- Decided: Aug 13, 2004 after 7 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: 3 generations back to K943168 (1994). 4 ancestors in all.
4 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)
- K012740: Clearfil AP-X, Kuraray Medical, Inc. (2001) Summary page 1.
- K023002: Clearfil AP-X PLT, Kuraray Medical, Inc. (2002) Summary page 1.
- K863092: Dental Composite Restorative, Dentsply Intl. (1986) Summary page 1.

## Most influential descendants
- K192510: DIAFIL & DIAFIL Capsule (2020), 2 descendants of its own
- K261093: Diafil (2026), 0 descendants of its own
- K210421: Diafil & Diafil Capsule (2021), 0 descendants of its own
- K193496: CharmFil (2020), 0 descendants of its own

## Indications for use
DenFilTM is indicated for the following restorative applications; 1. Class: I, II, V restorations of posterior teeth 2. Class 111, IV, V restorations of anterior teeth 3. Cervical cavities or defects involving root surfaces

Source page: https://510kreport.com/device/K042124
Methodology: https://510kreport.com/methodology