# K022066: Registrado X-Tra

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Aug 14, 2002 after 50 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Registrado X-tra is intended for reproducing the structure of a patient's teeth and gums, to provide models in bite registration, fixing of facebow registration, and as a locator material for an intraoral pin tracing template.

Source page: https://510kreport.com/device/K022066
Methodology: https://510kreport.com/methodology