Invisalign IPR Sub-Assembly

GUDID 00850042861349

Align Technology, Inc.

Orthodontic space maintainer

• Primary Device ID: 00850042861349
• NIH Device Record Key: fb487629-6059-41c7-a24b-15a208756013
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invisalign IPR Sub-Assembly
• Version Model Number: 20191
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850042861349 [Primary]

FDA Product Code

• DZP: Instrument, Diamond, Dental

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00850042861349]

High-level Disinfectant

[00850042861349]

High-level Disinfectant

[00850042861349]

High-level Disinfectant

[00850042861349]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

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• 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