# K041028: Crown Delta Hydrophilic Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Crown Delta Corp.
- Decided: May 14, 2004 after 23 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
Crown Delta's Hydrophilic vinyl polysiloxane impression material will be used for making impressions of the teeth and gums of patients requiring models for study and/or for production of restorative prosthetic devices. The impression material is intended to be applied via a dual barrel cartridge system either into an impression tray or directly onto the patient's teeth. The "hydrophilic" enhancement will enable production of more accurate impression when adverse conditions (e.g. the presence of blood or saliva) are present.

Source page: https://510kreport.com/device/K041028
Methodology: https://510kreport.com/methodology