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510(k) Data Aggregation

    K Number
    K250512
    Device Name
    Augmented Gingival Matrix
    Manufacturer
    Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.
    Date Cleared
    2025-12-05

    (287 days)

    Product Code
    NPL
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K252605
    Device Name
    mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
    Manufacturer
    Medspira, LLC
    Date Cleared
    2025-12-05

    (109 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252841
    Device Name
    REAL INTELLIGENCE™ CORI™ XT (CORI XT)
    Manufacturer
    Blue Belt Technologies, Inc.
    Date Cleared
    2025-12-05

    (88 days)

    Product Code
    OLO,HSX,JWH,KWS,MBH
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252504
    Device Name
    Gastric Alimetry
    Manufacturer
    Alimetry , Ltd.
    Date Cleared
    2025-12-05

    (119 days)

    Product Code
    MYE
    Regulation Number
    876.1735
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252142
    Device Name
    Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
    Manufacturer
    Shenzhen Siken 3D Technology Development Co., Ltd.
    Date Cleared
    2025-12-05

    (150 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250711
    Device Name
    VSP Orthopedics System
    Manufacturer
    3D Systems, Inc.
    Date Cleared
    2025-12-05

    (270 days)

    Product Code
    PBF
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250795
    Device Name
    PUREVUE™ FMS
    Manufacturer
    W.O.M. World OF Medicine GmbH
    Date Cleared
    2025-12-05

    (266 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    Device Description
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    K Number
    K252465
    Device Name
    Any-Core
    Manufacturer
    Mediclus Co., Ltd.
    Date Cleared
    2025-12-05

    (121 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    Device Description
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    K Number
    K252825
    Device Name
    Manual Wheelchair (W45)
    Manufacturer
    Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.
    Date Cleared
    2025-12-05

    (91 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K252151
    Device Name
    els unibond
    Manufacturer
    Saremco Dental AG
    Date Cleared
    2025-12-05

    (149 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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