Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB)

GUDID 00816063022091

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) is used to introduce mandibular skeletal changes in the treatment of Class I and Class II malocclusion, severe open bite, severe overjet, deep bite, skeletally narrow jaw, and those who require surgical correction.

Align Technology, Inc.

Orthodontic progressive aligner

• Primary Device ID: 00816063022091
• NIH Device Record Key: 004055c7-b019-4331-b5b3-c0e542d988a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB)
• Version Model Number: 221572
• 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	00816063022091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232233

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: 2024-05-24
• Device Publish Date: 2024-05-16

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