# K981970: Algetral, Cavex Chromatic, CA 37 Superior Pink, CA 37 Fast Set, Cavex Rainbow, Cavex Impressional Normal Setting, Cavexi

- Pathway: 510(k) (Traditional)
- Applicant: Cavex Holland BV
- Decided: Sep 2, 1998 after 90 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
Algetral and Cavex Chromatic are dental impression materials based on alginate. They are 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. They are general purpose impression materials for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc. Cavex Chromatic has the special characteristic of being a color-changing alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to off-white indicating the end of the setting time in the mouth.

Source page: https://510kreport.com/device/K981970
Methodology: https://510kreport.com/methodology