iTero Articulator Kit

GUDID 00816063020677

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ALIGN TECHNOLOGY, INC.

Dental CAD/CAM system, chairside

• Primary Device ID: 00816063020677
• NIH Device Record Key: 0262e65f-f00e-4c0f-95c7-d245aec89af2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTero Articulator Kit
• Version Model Number: 107806
• Company DUNS: 013831768
• Company Name: ALIGN TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816063020677 [Primary]

FDA Product Code

• EJP: Articulators

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

Devices Manufactured by ALIGN TECHNOLOGY, INC.

• 00816063023777 - Invisalign Specifix Attachment System: 2026-02-17 The Invisalign Specifix Attachment System is a patient specific system for the bonding of 3D-printed attachments onto the patien
• 00816063023784 - lnvisalign Specifix Attachment System (include Engagement Features): 2026-02-17 The Invisalign Specifix Attachment System is a patient specific system for the bonding of 3D-printed attachments and engagement
• 00816063023760 - Gumlines: 2026-01-09 iTero Gumlines
• 00816063021377 - Invisalign Go Express: 2025-09-23 Aligner
• 00816063022923 - Vivera™ 3D retainers: 2025-04-23 Vivera™ 3D retainers are 3D printed retainers indicated for maintaining and preventing movement of a patient's dentition.
• 00816063023067 - iTero Lumina Pro: 2025-03-14 iTero Lumina Pro Software
• 00816063022800 - Invisalign Pre-Formed Attachment System: 2025-03-10 The Invisalign Pre-Formed Attachment System is a doctor prescribed, patient specific system for the bonding of 3D-printed attach
• 00816063022213 - iTero Lumina Pro: 2024-11-27 iTero Lumina Pro US Cart Configuration