Invisalign Signature Smile

GUDID 00816063020523

Aligner

ALIGN TECHNOLOGY, INC.

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• Primary Device ID: 00816063020523
• NIH Device Record Key: dde7d0f6-ee0b-4e81-802d-e40e196bb83d
• Commercial Distribution Discontinuation: 2019-03-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Invisalign Signature Smile
• Version Model Number: 9025
• 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	00816063020523 [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: 2019-03-11
• Device Publish Date: 2019-03-01

On-Brand Devices [Invisalign Signature Smile]

• 00816063020448: Sequential Aligner
• 00816063020523: Aligner