iTero 5D Scanning Unit

GUDID 00816063020875

Scanning unit

ALIGN TECHNOLOGY, INC.

Dental CAD/CAM system, chairside

• Primary Device ID: 00816063020875
• NIH Device Record Key: f12f8efb-2991-4a5a-b36c-0b108deb031c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTero 5D Scanning Unit
• Version Model Number: 211871
• 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: true
• 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	00816063020875 [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: 2021-06-14
• Device Publish Date: 2021-06-04

On-Brand Devices [iTero 5D Scanning Unit]

• 00816063020875: Scanning unit
• 00816063020868: Scanning unit