# K013336: Xantalgin Crono

- Pathway: 510(k) (Traditional)
- Applicant: Cavex Holland BV
- Decided: Oct 29, 2001 after 20 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K141092: MARK3 (2014), 0 descendants of its own

## Indications for use
Xantalgin Crono is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc. Xantalgin Crono has the special characteristic of being a color-changing alginate: it becomes blue upon contact with water in the mixing bowl. It changes to violet indicating the end of the mixing time and loading the tray. Then it changes to pink indicating the moment to insert the tray into the mouth of the patient and finally it changes to white indicating the end of the setting time in the mouth.

Source page: https://510kreport.com/device/K013336
Methodology: https://510kreport.com/methodology