# K043054: Genie Magic Mix Ultra Hydrophilic Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Sultan Chemists, Inc.
- Decided: Feb 18, 2005 after 105 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
Sultan Genie Magic MiXTM Ultra Hydrophilic Impression Material is intended for use as a dental impression material, compatible with all techniques including dual-phase, mono-phase and dual impression techniques. The material is dispensed from an automatic mixing machine system and placed into dental impression trays (metal or plastic) and is used to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.

Source page: https://510kreport.com/device/K043054
Methodology: https://510kreport.com/methodology