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Clearjoy Dental Aligner

Ulab Systems, Inc. · Model 1 · UDI-DI 00860461001714

NXC Prescription

510(k) clearances

18,531

Adverse events (1 deaths)

Recalls

Facilities

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.

Recalls

Date	Firm	Reason
2024-11-22	3M Company - Health Care Business	Attachments may not mate with the tooth as intended in the digital treatment design.
2024-11-04	Straight Smile, LLC	Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindicatio

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.