Unismile Clear Aligner

GUDID 00860012674619

VITANG TECHNOLOGY, LLC

Orthodontic progressive aligner

• Primary Device ID: 00860012674619
• NIH Device Record Key: 76b70990-8e53-4745-a1fa-8ffabb8418c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unismile Clear Aligner
• Version Model Number: Aligners
• Company DUNS: 074802668
• Company Name: VITANG TECHNOLOGY, LLC
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	00860012674619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191837

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: 2024-10-22
• Device Publish Date: 2024-10-14

On-Brand Devices [Unismile Clear Aligner]

• 10860012674647: Full Package
• 00860012674657: tray seater and hook
• 00860012674633: Attachment Guide
• 00860012674626: Retainer
• 00860012674619: Aligners