AlgiMac

GUDID D105MI901211

AlgiMac Alginate Substitute, Fast Set Mint Flavor -50mL Cartridge

Surgimac LLC

Silicone dental impression material

• Primary Device ID: D105MI901211
• NIH Device Record Key: 3f0ee57f-8464-4271-9bc6-4e98ce78c298
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AlgiMac
• Version Model Number: MI-9012-1
• Company DUNS: 060635048
• Company Name: Surgimac LLC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D105MI901211 [Primary]

FDA Product Code

• ELW: Material, Impression

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: 2025-06-26
• Device Publish Date: 2025-06-18

On-Brand Devices [AlgiMac]

• D105MI90130: AlgiMac Alginate Substitute, Fast Set Mint Flavor, box of 4-50mL Cartridges
• D105MI901311: AlgiMac Alginate Substitute, Fast Set Mint Flavor - 50mL Cartridge
• D105MI90120: AlgiMac Alginate Substitute, Fast Set Mint Flavor, box of 8-50mL Cartridges
• D105MI901211: AlgiMac Alginate Substitute, Fast Set Mint Flavor -50mL Cartridge