Invisalign System with Mandibular advancement - precision wings

GUDID 00816063022152

The Invisalign System with Mandibular advancement - precision wings is used to treat patients with Class I and Class II malocclusion, severe open bit, severe overjet, deep bit, skeletally narrow jaw, and dental prostheses/implants, and/or those who require surgical correction.

Align Technology, Inc.

Orthodontic progressive aligner

• Primary Device ID: 00816063022152
• NIH Device Record Key: 0dde2957-b893-425f-9ae9-3c95ce297137
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invisalign System with Mandibular advancement - precision wings
• Version Model Number: 222716
• 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: false
• 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	00816063022152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181739

FDA Product Code

• NXC: Aligner, Sequential

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: 2023-08-01
• Device Publish Date: 2023-07-24

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