Clearjoy Dental Aligner FG0094-05

GUDID 00860461001714

The Clearjoy Dental Aligner kit is a line extension of the uLab Systems Dental Aligner Kit and 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: 00860461001714
• NIH Device Record Key: 8e4de69d-c71f-4acb-9fa4-18c6aaa68fc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clearjoy Dental Aligner
• Version Model Number: 1
• Catalog Number: FG0094-05
• 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	00860461001714 [Primary]

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: 2023-11-10
• Device Publish Date: 2023-11-02

Devices Manufactured by Ulab Systems, Inc.

• 00860461001783 - uLab Systems uDesign: 2024-05-28 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imp
• 00860461001714 - Clearjoy Dental Aligner: 2023-11-10The Clearjoy Dental Aligner kit is a line extension of the uLab Systems Dental Aligner Kit and 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.
• 00860461001714 - Clearjoy Dental Aligner: 2023-11-10 The Clearjoy Dental Aligner kit is a line extension of the uLab Systems Dental Aligner Kit and is an orthodontic treatment syste
• 00860461001769 - uLab Systems uDesign: 2023-11-10 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imp
• 00860002380087 - uLab Systems uDesign: 2023-04-04 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imp
• 00860002380094 - uLab Systems Dental Aligner: 2022-06-09 The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctor-prescribed, clear, thin, plastic
• 00860002380049 - uLab Systems uDesign: 2021-07-27 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imp
• 00860002380070 - uLab Systems uDesign: 2021-05-18 The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imp
• 00860002380063 - uLab Systems Dental Aligner: 2020-10-20