MacBite

GUDID D105BR9004MB0

MacBite Registration Material, Mint Chocolate Chip Fast Set, 2 - 50 mL Cartridges and 6 Mixing Tips

Surgimac LLC

Dental articulation paste/solution

• Primary Device ID: D105BR9004MB0
• NIH Device Record Key: 9f5dc1f7-1c62-462e-b524-31e50640ce12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MacBite
• Version Model Number: BR-9004-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	D105BR9004MB0 [Unit of Use]
HIBCC	D105BR9004MB2 [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

On-Brand Devices [MacBite]

• D10512178EA1: Mac Bite Registration Material - 50ml
• D105121784: Mac Bite Registration Material - 50ml, 4/BX
• D105BR9005MB0: MacBite Registration Material, Mint Chocolate Chip Super Fast Set, 2 - 50 mL Cartridges and 6 Mi
• D105BR9004MB0: MacBite Registration Material, Mint Chocolate Chip Fast Set, 2 - 50 mL Cartridges and 6 Mixing T
• D105BR9003MB0: MacBite Registration Material, Unflavored Super Fast Set, 2 - 50 mL Cartridges and 6 Mixing Tips
• D105BR9002MB0: MacBite Registration Material, Unflavored Fast Set, 2 - 50 mL Cartridges and 6 Mixing Tips
• D105BR9001MB0: MacBite Registration Material, Unflavored Regular Set, 2 - 50 mL Cartridges and 6 Mixing Tips
• D105BR9005MB11: MacBite Registration Material, Mint Chocolate Chip Super Fast - 50 mL Cartridge
• D105BR9004MB11: MacBite Registration Material, Mint Chocolate Chip Fast - 50 mL Cartridge
• D105BR9003MB11: MacBite Registration Material, Unflavored Super Fast - 50 mL Cartridge
• D105BR9002MB11: MacBite Registration Material, Unflavored Fast - 50 mL Cartridge
• D105BR9001MB11: MacBite Registration Material, Unflavored Regular - 50 mL Cartridge