Invisalign System with Mandibular advancement - enhanced precision wings

GUDID 00816063022145

The Invisalign System with Mandibular advancement - enhanced precision wings (EPW) 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. The EPW are modified precision wings with longer and curved wings, with an added rib on buccal side, which are designed to optimize mandibular advancement.

Align Technology, Inc.

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• Primary Device ID: 00816063022145
• NIH Device Record Key: acda1cdd-23b3-4cea-af4f-0183461c2927
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invisalign System with Mandibular advancement - enhanced precision wings
• Version Model Number: 222715
• 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	00816063022145 [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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