MacBite

GUDID D105121784

Mac Bite Registration Material - 50ml, 4/BX

Surgimac LLC

Silicone dental impression material

• Primary Device ID: D105121784
• NIH Device Record Key: c9934b69-55fe-4a72-bfd6-dc19adfd6b79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MacBite
• Version Model Number: 12178-4
• Company DUNS: 060635048
• Company Name: Surgimac LLC
• Device Count: 4
• 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	D105121784 [Unit of Use]
HIBCC	D10512178BX4 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221668

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: 2025-05-15
• Device Publish Date: 2025-05-07

On-Brand Devices [MacBite]

• D10512178EA1: Mac Bite Registration Material - 50ml
• D105121784: Mac Bite Registration Material - 50ml, 4/BX