# K051207: Cavex Orthotrace

- Pathway: 510(k) (Traditional)
- Applicant: Cavex Holland BV
- Decided: Jun 21, 2005 after 41 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K151535: Cavex Cream Alginate (2015), 0 descendants of its own
- K141092: MARK3 (2014), 0 descendants of its own

## Indications for use
Cavex Orthotrace alginate impression material 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. Cavex Orthotrace has an extra fast setting time, high elasticity, high tear resistance, can be poured twice with gypsum and is presented in a attractive fuchsia-coloured powder with a red-fruit flavour. Therefore, Cavex Orthotrace is particularly suited for orthodontics

Source page: https://510kreport.com/device/K051207
Methodology: https://510kreport.com/methodology