# K053391: X-Tra Fil

- Pathway: 510(k) (Abbreviated)
- Applicant: Voco GmbH
- Decided: Feb 15, 2006 after 72 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 K950991 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040144: Quixx Posterior Restorative, Dentsply International (2004) Summary page 1.

## Indications for use
x-tra fil is intended for light curing class I and class II posterior fillings and core build-up.

Source page: https://510kreport.com/device/K053391
Methodology: https://510kreport.com/methodology