Attachment Template

GUDID 00816063022169

The Invisalign™ Attachment Templates are disposable polyurethane accessory to Invisalign System and are intended to guide the placement of dental composite (material provided by doctor) to the tooth surface to create shapes known as attachments, which are used for aligner retention or optimized aligner force system for tooth movement. The configuration and types of attachments shapes are defined by the treatment plan.

Align Technology, Inc.

Orthodontic resin positioning tray

• Primary Device ID: 00816063022169
• NIH Device Record Key: e1053043-702d-42c6-84ee-49adaac422c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Attachment Template
• Version Model Number: 100012
• 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: 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	00816063022169 [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

Devices Manufactured by Align Technology, Inc.

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• 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)