Straight T Clear Dental Aligner

GUDID 00860005619016

Clear Dental Aligner

Straight-T LLC

Orthodontic aligner auxiliary attachment kit

• Primary Device ID: 00860005619016
• NIH Device Record Key: f2a3b1d5-bb00-408c-b748-03bedd6bee3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straight T Clear Dental Aligner
• Version Model Number: X
• Company DUNS: 043053493
• Company Name: Straight-T 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00860005619016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201450

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: 2020-10-30
• Device Publish Date: 2020-10-22