Invisalign Signature Smile

GUDID 00816063020448

Sequential Aligner

ALIGN TECHNOLOGY, INC.

Orthodontic appliance system, progressive

• Primary Device ID: 00816063020448
• NIH Device Record Key: fb664d4a-d4f8-433a-8ecf-7d5c741d54d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invisalign Signature Smile
• Version Model Number: 9021
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816063020448 [Primary]

FDA Product Code

• NXC: Aligner, Sequential

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-25
• Device Publish Date: 2018-06-15

On-Brand Devices [Invisalign Signature Smile]

• 00816063020448: Sequential Aligner
• 00816063020523: Aligner