iTero Lumina scanning unit

GUDID 00816063021599

Scanning unit (wand)

Align Technology, Inc.

Dental milling system, CAD/CAM, chairside

• Primary Device ID: 00816063021599
• NIH Device Record Key: c21c9fba-3854-498e-92ff-87afe682e6a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTero Lumina scanning unit
• Version Model Number: 214500
• Company DUNS: 013831768
• Company Name: Align Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• 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	00816063021599 [Primary]

FDA Product Code

• NOF: System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

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: 2024-02-09
• Device Publish Date: 2024-02-01

On-Brand Devices [iTero Lumina scanning unit]

• 00816063021599: Scanning unit (wand)
• 00816063022138: Scanning unit (wand)