# K193496: CharmFil

- Pathway: 510(k) (Traditional)
- Applicant: Dentkist, Inc.
- Decided: May 6, 2020 after 141 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: 4 generations back to K943168 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042124: Denfil, Vericom Co., Ltd. (2004) Summary page 4.

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

Source page: https://510kreport.com/device/K193496
Methodology: https://510kreport.com/methodology