iTero Element 5D upgrade, Kit US

GUDID 00816063020653

Scanner Upgrade Kit

ALIGN TECHNOLOGY, INC.

Dental CAD/CAM system, chairside

• Primary Device ID: 00816063020653
• NIH Device Record Key: 76a84cd7-73b3-461d-a860-63b8b6049065
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTero Element 5D upgrade, Kit US
• Version Model Number: 209176
• 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	00816063020653 [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

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