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510(k) Data Aggregation

    K Number
    K221972
    Device Name
    Warantec Custom Abutment
    Manufacturer
    Warantec Co., Ltd,
    Date Cleared
    2023-10-02

    (454 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Warantec Co., Ltd,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Warantec dental abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation. All digitally designed abutments for use with Warantec Custom Abutments are intended to be sent to a Warantec-validated milling center for manufacture.
    Device Description
    Warantec Custom Abutments are used for cement-retained crowns and bridges using customized abutment considering based on the patient's mouth using CAD/CAM system. That is customized abutment considering shape of the final prosthesis based on the patient's mouth model using CAD/CAM system during the manufacturing. The Warantec Custom Abutment are made of Ti-6A1-4V ELI (ASTM F136). These devices are supplied non-sterile and autoclaved by the end user and intended for single use only. Warantec Custom Abutments are compatible with IU Implant System.
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    K Number
    K221969
    Device Name
    IU Implant System Abutment
    Manufacturer
    Warantec Co., Ltd,
    Date Cleared
    2023-05-12

    (311 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Warantec Co., Ltd,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Warantec dental abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation.
    Device Description
    The IU Implant System Abutment is a dental implant superstructure made of titanium alloy. It is an abutment used to support or maintain the restoration after the implantation of the fixture in the oral cavity. The abutments are provided non-sterile and should be sterilized before use.
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