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510(k) Data Aggregation
K Number
K190394Device Name
SunClear Aligner system
Manufacturer
Date Cleared
2019-12-16
(300 days)
Product Code
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Sun Dental Laboratories, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SunClear Aligner system is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). SunClear Aligners positions teeth by way of continuous gentle force.
Device Description
SunClear Aligners consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3-D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. SunClear Aligners are intended as an alternative to conventional bracket technology and fixed appliances for the treatment of patients with malocclusion.
The proprietary software generates the final image of a treated state and then interpolates a series of images that represent the intermediate teeth states. The dental practitioner then reviews these images to depict, edit, view, monitor, and approve an orthodontic treatment plan.
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