DX-Mixer

GUDID 08800017900278

The dental impression material mixed with a base and a catalyst is used in a dental clinic rapidly to obtain the dental impression. The dental impression material is normally housed in cartridge assembly. The impression cartridge assembly consists of a base impression cartridge and a catalyst impression cartridge parts each.

DXM CO., LTD

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• Primary Device ID: 08800017900278
• NIH Device Record Key: f6a47348-e931-4066-a5ec-b47673dda958
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DX-Mixer
• Version Model Number: 110
• Company DUNS: 688797315
• Company Name: DXM CO., LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800017900278 [Package]; Contains: 08800017901657; Package: Zip bag [48 Units]; In Commercial Distribution
GS1	08800017900360 [Package]; Contains: 08800017901657; Package: Zip bag [500 Units]; In Commercial Distribution
GS1	08800017901657 [Primary]

FDA Product Code

• EID: Syringe, Restorative And Impression Material

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-03
• Device Publish Date: 2023-07-26

On-Brand Devices [DX-Mixer]

• 08800017900278: The dental impression material mixed with a base and a catalyst is used in a dental clinic rapid
• 08800017900438: The dental impression material mixed with a base and a catalyst is used in a dental clinic rapid