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

Devices Manufactured by Align Technology, Inc.

• 00816063022091 - Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB): 2024-05-24 Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) is used to introduce mandibular skeletal changes
• 00816063022138 - iTero Lumina Scanning Unit: 2024-02-23 Scanning unit (wand)
• 00816063021421 - iTero Lumina Cart upgrade from Element Plus: 2024-02-09 Upgrade kit for existing iTero users who upgrade their Plus scanner to Lumina scanner
• 00816063021438 - iTero Lumina Mobile Configuration: 2024-02-09 iTero Lumina Intraoral scanner Mobile Configuration
• 00816063021452 - iTero Lumina DOA Cart: 2024-02-09 Replacement package of iTero Lumina scanner in case of DOA
• 00816063021469 - iTero Lumina RMA Scanning Unit: 2024-02-09 Scanning unit (wand) replacement package
• 00816063021483 - iTero Lumina 25 Disposable Sleeves Box: 2024-02-09 Disposable single use sleeves box
• 00816063021599 - iTero Lumina scanning unit: 2024-02-09 Scanning unit (wand)