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510(k) Data Aggregation

    K Number
    K223454
    Device Name
    Custom-made Invisible Aligners
    Date Cleared
    2023-04-17

    (152 days)

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

    Zhejiang Yinchili Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Custom-made Invisible Aligners is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Custom-made Invisible Aligner positions teeth by way of continuous gentle force.
    Device Description
    The Custom-made Invisible Aligners System is a series of dental aligners that fabricated of clear, thin thermoformed plastic to progressively reposition the teeth. The product is made from a composite multilayer material with thermoplastic polyurethane and polyethylene terephthalate-1, 4-cyclohexanedimethanol ester (TPU+PETG). Corrective force to reposition the teeth is delivered via minor changes into a position in each subsequent aligner. They are designed to move the teeth to the target position and deliver desired clinical effect.
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    K Number
    K203624
    Device Name
    Custom-made Invisible Aligners
    Date Cleared
    2022-06-16

    (552 days)

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

    Zhejiang Yinchili Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Custom-made Invisible Aligners is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Custom-made Invisible Aligner positions teeth by way of continuous gentle force.
    Device Description
    The Custom-made Invisible Aligners System is a series of dental aligners that are fabricated of clear, thin thermoformed Polyethylene terephthalate (PETG) plastic to progressively reposition the teeth. Corrective force to reposition the teeth is delivered via minor changes into a position in each subsequent aligner.
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