Clearjoy Dental Aligner

Basic Information

• Brand Name: Clearjoy Dental Aligner
• Primary DI: 00860461001714
• Version / Model: 1
• Catalog Number: FG0094-05
• Company Name: Ulab Systems, Inc.
• Labeler DUNS: 081092722
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-02
• Public Version: 1
• Public Version Date: 2023-11-10
• Public Version Status: New
• Public Device Record Key: 8e4de69d-c71f-4acb-9fa4-18c6aaa68fc7

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NXC	Aligner, Sequential	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44738	Orthodontic progressive aligner	A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860461001714	GS1