Invisalign Pre-Formed Attachment System

GUDID 00816063021193

The Invisalign Pre-Formed Attachment System is a doctor prescribed, patient specific system for the bonding of 3D-printed attachments onto the patient’s teeth. The pre-formed attachment system contains two sets of attachment positioners for each quadrant that requires attachments.

Align Technology, Inc.

Orthodontic aligner auxiliary attachment kit

• Primary Device ID: 00816063021193
• NIH Device Record Key: 6f4f8de3-8004-4432-916e-9d599c011d12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invisalign Pre-Formed Attachment System
• Version Model Number: 9030
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00816063021193 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222894

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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