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510(k) Data Aggregation

    K Number
    K251758
    Device Name
    Serafin®
    Manufacturer
    TNS Co., Ltd.
    Date Cleared
    2025-09-11

    (94 days)

    Product Code
    NXC
    Regulation Number
    872.5470
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K232074,K220287
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Serafin is intended for the orthodontic treatment of malocclusion in patients with mixed and permanent dentition.

    Device Description

    Serafin® is composed of series of transparent removable orthodontic appliances manufactured using thermoforming technology based on a 3D model of the patient's teeth, customized according to a Dental Practitioner's specific prescription, indicated for treatment of dental malocclusion by applying continuous gentle force to realign teeth.

    The time for each stage of aligner usage is set in the personal treatment plan, and this varies for each patient and the Dental Practitioner's choice. Each set of aligners needs to be worn for at least 2 weeks. Patients the total treatment time lasts about 6 to 24 months.

    AI/ML Overview

    N/A

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