# K123824: Vitro Fil LC

- Pathway: 510(k) (Traditional)
- Applicant: Dfl Industria E Comercio SA
- Decided: Feb 21, 2013 after 71 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K946100 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925032: 3M Vitremer Tri-Cure Glass Ionomer System, 3M Company (1992) Summary page 1.
- K101869: Proglass Cements (One, Two Two LC, Nine, Plus, Silver), Silmet, Ltd. (2010) Summary page 1.
- K913884: Fuji II LC, G-C Intl. Corp. (1991) Summary page 1.

## Indications for use
As a structural reinforcement for fabricating and/or repairing Class III and Class V restorations Restoration of root surface caries Restorations of cervical erosions Small Class I restorations Primary teeth restoration Core build up Liner

Source page: https://510kreport.com/device/K123824
Methodology: https://510kreport.com/methodology