Clearly

GUDID 00860010675700

Sequential clear aligner system to straighten teeth

Precision Align LLC

Orthodontic progressive aligner

• Primary Device ID: 00860010675700
• NIH Device Record Key: de424ede-ed4e-406b-8856-56b9670831d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clearly
• Version Model Number: 1
• Company DUNS: 100126818
• Company Name: Precision Align 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: true
• Lot Batch: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010675700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212772

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: 2023-08-01
• Device Publish Date: 2023-07-24