# K081084: Colorise Rigid

- Pathway: 510(k) (Special)
- Applicant: Zhermack S.P.A.
- Decided: May 14, 2008 after 28 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
COLORISE RIGID is a conversational two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Source page: https://510kreport.com/device/K081084
Methodology: https://510kreport.com/methodology