MacBite

GUDID D105BR9002MB0

MacBite Registration Material, Unflavored Fast Set, 2 - 50 mL Cartridges and 6 Mixing Tips

Surgimac LLC

Dental articulation paste/solution

• Primary Device ID: D105BR9002MB0
• NIH Device Record Key: 4ce8ea73-b671-4803-86fe-7773ed4e3fd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MacBite
• Version Model Number: BR-9002-MB
• Company DUNS: 060635048
• Company Name: Surgimac LLC
• Device Count: 2
• 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	D105BR9002MB0 [Unit of Use]
HIBCC	D105BR9002MB2 [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: 2025-06-12
• Device Publish Date: 2025-06-04

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• D105BR9001MB11: MacBite Registration Material, Unflavored Regular - 50 mL Cartridge