Invisalign Palatal Expander

GUDID 00816063021391

Palatal Expanders

Align Technology, Inc.

Orthodontic palate expander/teeth aligner, self-removable

• Primary Device ID: 00816063021391
• NIH Device Record Key: f94ff2cd-2e9c-4095-8a65-a7a8f2f6ce13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invisalign Palatal Expander
• Version Model Number: 9031
• 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	00816063021391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232887

FDA Product Code

• NXC: Aligner, Sequential
• PNN: Orthodontic Software

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: 2024-01-11
• Device Publish Date: 2024-01-03

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