VIVID Aligners

GUDID 00860011027201

Sequential aligner

Ortho Dent Laboratory Inc

Orthodontic progressive aligner

• Primary Device ID: 00860011027201
• NIH Device Record Key: d219e2b9-be39-4af0-845d-8ba50682a4db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIVID Aligners
• Version Model Number: 7201
• Company DUNS: 623178647
• Company Name: Ortho Dent Laboratory 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: false
• Serial Number: false
• 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	00860011027201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190003

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: 2023-12-28
• Device Publish Date: 2023-12-20