iTero Element 5D LC Upgrade, Kit US

GUDID 00816063020646

Scanner Upgrade Kit

ALIGN TECHNOLOGY, INC.

Dental CAD/CAM system, chairside

• Primary Device ID: 00816063020646
• NIH Device Record Key: 5b979ba4-fbc7-44fa-a131-f089b22ebf9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTero Element 5D LC Upgrade, Kit US
• Version Model Number: 209157
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816063020646 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193659

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: 2020-06-12
• Device Publish Date: 2020-06-04

Devices Manufactured by ALIGN TECHNOLOGY, INC.

• 00816063022091 - Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB): 2024-05-24 Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) is used to introduce mandibular skeletal changes
• 00816063022138 - iTero Lumina Scanning Unit: 2024-02-23 Scanning unit (wand)
• 00816063021421 - iTero Lumina Cart upgrade from Element Plus: 2024-02-09 Upgrade kit for existing iTero users who upgrade their Plus scanner to Lumina scanner
• 00816063021438 - iTero Lumina Mobile Configuration: 2024-02-09 iTero Lumina Intraoral scanner Mobile Configuration
• 00816063021452 - iTero Lumina DOA Cart: 2024-02-09 Replacement package of iTero Lumina scanner in case of DOA
• 00816063021469 - iTero Lumina RMA Scanning Unit: 2024-02-09 Scanning unit (wand) replacement package
• 00816063021483 - iTero Lumina 25 Disposable Sleeves Box: 2024-02-09 Disposable single use sleeves box
• 00816063021599 - iTero Lumina scanning unit: 2024-02-09 Scanning unit (wand)