iTero Lumina Pro intraoral scanning unit

GUDID 00816063022268

iTero Lumina Pro Scanning Unit, RMA Package US

Align Technology, Inc.

Intraoral optical scanning system

• Primary Device ID: 00816063022268
• NIH Device Record Key: b34d479e-369d-45a7-a7d5-c55177fb5d56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTero Lumina Pro intraoral scanning unit
• Version Model Number: 221925
• 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	00816063022268 [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

Devices Manufactured by Align Technology, Inc.

• 00816063022213 - iTero Lumina Pro: 2024-11-27 iTero Lumina Pro US Cart Configuration
• 00816063022237 - iTero Lumina Pro Mobile: 2024-11-27 iTero Lumina Pro US Mobile Configuration
• 00816063022268 - iTero Lumina Pro intraoral scanning unit: 2024-11-27iTero Lumina Pro Scanning Unit, RMA Package US
• 00816063022268 - iTero Lumina Pro intraoral scanning unit: 2024-11-27 iTero Lumina Pro Scanning Unit, RMA Package US
• 00816063022329 - iTero Lumina Pro DOA: 2024-11-27 iTero Lumina Pro US DOA Kit cart
• 00816063022428 - iTero Lumina Pro Upgrade: 2024-11-27 iTero Lumina Pro US Cart upgrade from Element Plus
• 00816063022442 - iTero Lumina Pro Mobile Upgrade: 2024-11-27 iTero Lumina Pro US Mobile upgrade from Element Plus
• 00816063022466 - iTero Lumina Pro Upgrade: 2024-11-27 iTero Lumina Pro US upgrade from Lumina
• 00816063022589 - iTero Lumina Pro Wand Barrier Sleeves: 2024-11-27 20 Barrier Sleeves, Lumina