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Genie Magic Mix Ultra Hydrophilic Impression Material

by Sultan Chemists, Inc.

510(k) K043054

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK043054 Date18 Feb 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ELW
Device Class
Class II
Regulation
21 CFR Part 872.3660
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Genie Magic Mix Ultra Hydrophilic Impression Material is a vinyl polysiloxane (VPS) impression material based on addition-cured chemistry. It is designed for dental use and supplied in 380 ml cartridges in two viscosities: regular and heavy body. Both viscosities are available in Rapid Set (2:10 total set time) and Standard Set (4:30 total set time) formulations. The material exhibits excellent hydrophilicity and is intended for making accurate dental impressions.

The device is supplied as a non-sterile, single-use material intended for use in dental clinical settings with automix dispensing machines. It is not indicated as MRI safe or unsafe in the provided data. Storage conditions are not specified in the device data. The product has received FDA 510(k) clearance under k-number K043054, with a decision date of 2005-02-18, and is classified as a Class II medical device under regulation number 872.3660.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is Genie Magic Mix Ultra Hydrophilic Impression Material used for?

    Genie Magic Mix Ultra Hydrophilic Impression Material is intended for making accurate dental impressions in dental clinical settings, as it is a vinyl polysiloxane (VPS) impression material based on addition-cured chemistry designed for dental use.

  • How is Genie Magic Mix Ultra Hydrophilic Impression Material supplied and what are its available forms?

    The material is supplied in 380 ml cartridges in two viscosities: regular and heavy body. Both viscosities are available in Rapid Set (2:10 total set time) and Standard Set (4:30 total set time) formulations, and it is designed for use with automix dispensing machines.

  • Is Genie Magic Mix Ultra Hydrophilic Impression Material sterile or single-use?

    The device is supplied as a non-sterile, single-use material intended for use in dental clinical settings, meaning it is not sterilized and should be discarded after one use to prevent cross-contamination.