Biodentine Mixer 01C0725

GUDID 14719871634322

cartridge mixer

SEPTODONT SAS SPECIALITES SEPTODONT

Dental amalgam mixer

• Primary Device ID: 14719871634322
• NIH Device Record Key: 808aa40d-8378-49df-9f26-86512033df7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biodentine Mixer
• Version Model Number: 01C0725
• Catalog Number: 01C0725
• Company DUNS: 275273795
• Company Name: SEPTODONT SAS SPECIALITES SEPTODONT
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719871634325 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	14719871634322 [Primary]

FDA Product Code

• EFD: Amalgamator, Dental, Ac-Powered

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: 2025-05-05
• Device Publish Date: 2025-04-25

Devices Manufactured by SEPTODONT SAS SPECIALITES SEPTODONT

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• 14719871634322 - Biodentine Mixer: 2025-05-05 cartridge mixer
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• 07897990328473 - SeptoMatrix Sectional Refill: 50 medium matrices: 2025-03-12 Preformed sectional matrices systems for Class II restorations.
• 07897990328480 - SeptoMatrix Sectional Refill: 50 small matrices: 2025-03-12 Preformed sectional matrices systems for Class II restorations.
• 07897990328718 - SeptoPlus Mandrel Refill: 1 mandrel snap: 2025-03-12 Mandrel for contra angle