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510(k) Data Aggregation

    K Number
    K242637
    Device Name
    MEM Clear Aligner System
    Date Cleared
    2025-05-21

    (260 days)

    Product Code
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEM Dental Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MEM Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The MEM Clear Aligner System repositions teeth by way of continuous gentle force.
    Device Description
    The MEM Clear Aligner System is a customized plastic orthodontic system, consisting of a series of transparent, removable aligners prescribed by a doctor to correct misaligned or crooked teeth. These customized, removable transparent plastic aligners gradually reposition teeth with continuous gentle pressure. The product is a series of transparent, removable orthodontic aligners, custom-made according to the dentist's prescription and designed using the "3Shape A/S (K171634)" software. They are manufactured using thermoforming technology. These aligners are designed to provide a comfortable teeth straightening experience and achieve optimal correction through precise design using advanced technology.
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    K Number
    K180952
    Device Name
    Ceramic Bracket
    Date Cleared
    2019-06-07

    (422 days)

    Product Code
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEM Dental Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ceramic Bracket is indicated for orthodontic movement of natural teeth.
    Device Description
    Ceramic bracket are designed to move teeth to improve their alignment. Ceramic bracket are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position. Ceramic bracket are intended for use in affixed to a tooth so that pressure can be exerted on the teeth. Use bonding supplies to bond the bracket on to a tooth. Use bonding supplies to bond the bracket on to a tooth. Ceramic bracket are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.
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