iTero Lumina Pro Upgrade

GUDID 00816063022466

iTero Lumina Pro US upgrade from Lumina

Align Technology, Inc.

Intraoral optical scanning system

• Primary Device ID: 00816063022466
• NIH Device Record Key: 0e6d61ec-2e7d-4c3b-9ac3-60c176374f10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTero Lumina Pro Upgrade
• Version Model Number: 221950
• Company DUNS: 013831768
• Company Name: Align Technology, Inc.
• 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: 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	00816063022466 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240573

FDA Product Code

• NTK: Caries Detector, Laser Light, Transmission

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: 2024-11-27
• Device Publish Date: 2024-11-19

On-Brand Devices [iTero Lumina Pro Upgrade]

• 00816063022466: iTero Lumina Pro US upgrade from Lumina
• 00816063022428: iTero Lumina Pro US Cart upgrade from Element Plus