uLab Systems Dental Aligner

GUDID 00860002380056

ULAB SYSTEMS, INC.

Dental CAD/CAM system, laboratory

• Primary Device ID: 00860002380056
• NIH Device Record Key: 167df33d-2aee-4d86-9ef3-ee8a2d7baaa2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uLab Systems Dental Aligner
• Version Model Number: FG0094
• Company DUNS: 081092722
• Company Name: ULAB SYSTEMS, 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: 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	00860002380056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192596

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: 2020-07-28
• Device Publish Date: 2020-07-20

On-Brand Devices [uLab Systems Dental Aligner]

• 00860002380056: FG0094
• 00860002380063: FG0094 Rev. D
• 00860002380094: The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctor-