BRIUS Clear Aligner

GUDID 00860002991016

BRIUS Clear Aligner

Brius Technologies Inc

Orthodontic progressive aligner

• Primary Device ID: 00860002991016
• NIH Device Record Key: ca33b37c-937a-4b87-b690-26da0582969a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRIUS Clear Aligner
• Version Model Number: 1
• Company DUNS: 117587817
• Company Name: Brius Technologies 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	00860002991016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202792

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: 2023-03-14
• Device Publish Date: 2023-03-06

Devices Manufactured by Brius Technologies Inc

• 00860002991016 - BRIUS Clear Aligner: 2023-03-14BRIUS Clear Aligner
• 00860002991016 - BRIUS Clear Aligner: 2023-03-14 BRIUS Clear Aligner
• 00860002991009 - BRIUS: 2020-10-30