# K141092: MARK3

- Pathway: 510(k) (Traditional)
- Applicant: Cavex Holland BV
- Decided: Dec 4, 2014 after 220 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
Longest line of descent: 1 generation back to K981970 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981970: Algetral, Cavex Chromatic, CA 37 Superior Pink, CA 37 Fast Set, Cavex Rainbow, Cavex Impressional Normal Setting, Cavexi, Cavex Holland BV (1998) Summary page 4.
- K011419: Cavex Colorchange, Cavex Holland BV (2001) Summary page 4.
- K051207: Cavex Orthotrace, Cavex Holland BV (2005) Summary page 4.
- K013336: Xantalgin Crono, Cavex Holland BV (2001) Summary page 4.
- K023466: Tulip Alginate Impression Material, Cavex Holland BV (2002) Summary page 4.
- K032116: Tulip Colorswitch, Cavex Holland BV (2003) Summary page 4.

## Indications for use
MARK3 is an irreversible hydrocolloid dental impression material used by the dentist 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 materials for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions.

Source page: https://510kreport.com/device/K141092
Methodology: https://510kreport.com/methodology