# K020242: Emulate Fast Set and Emulate Regular Set

- Pathway: 510(k) (Traditional)
- Applicant: Cavex Holland BV
- Decided: Apr 17, 2002 after 84 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
emulate Fast Set and emulate Regular Set 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.

Source page: https://510kreport.com/device/K020242
Methodology: https://510kreport.com/methodology