Materialise Mimics Enlight CMF Orthognathic and Trauma Planner

GUDID 05404028000946

Materialise Mimics Enlight CMF Orthognathic and Trauma Planner

Materialise NV

CAD/CAM software

• Primary Device ID: 05404028000946
• NIH Device Record Key: 73f4c737-0612-4525-93e9-f154baa9b39c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Materialise Mimics Enlight CMF
• Version Model Number: Orthognathic and Trauma Planner
• Catalog Number: Orthognathic and Trauma Planner
• Company DUNS: 373139427
• Company Name: Materialise NV
• 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: false
• Lot Batch: true
• Serial Number: false
• 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	05404028000946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223427

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2025-05-20
• Device Publish Date: 2025-05-12

On-Brand Devices [Materialise Mimics Enlight CMF]

• 05404028000816: Mimics Enlight CMF Reconstruction Planner
• 05404028000953: Mimics Enlight CMF Reconstruction Planner
• 05404028000946: Materialise Mimics Enlight CMF Orthognathic and Trauma Planner