uLab Systems Dental Aligner

GUDID 00860002380094

The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctor-prescribed, clear, thin, plastic removable aligners. Patients are seen in a dental office where a dental professional (dentist/orthodontist) scans or takes a physical impression of the teeth, which is then used to fabricate the aligners. The aligners are designed by dental professionals using uLab Systems technology. The aligners are made of aesthetic and medical grade materials. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient’s teeth gradually to the ideal position.

ULAB SYSTEMS, INC.

Orthodontic progressive aligner

• Primary Device ID: 00860002380094
• NIH Device Record Key: d177a354-9038-4149-935b-a04c857f00e0
• 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	00860002380094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211510

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: 2022-06-09
• Device Publish Date: 2022-06-01

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-