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510(k) Data Aggregation

    K Number
    K254063

    Validate with FDA (Live)

    Device Name
    iCEM Universal Plus
    Manufacturer
    Kulzer, LLC
    Date Cleared
    2025-12-19

    (2 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Abbreviated
    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
    K253373

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    Device Name
    Southern Craniomaxillofacial (CMF) System
    Manufacturer
    Southern Medical (Pty) , Ltd.
    Date Cleared
    2025-12-19

    (80 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    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
    K252976

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    Device Name
    Park Dental Nylon MAD
    Manufacturer
    Park Dental Research Corp.
    Date Cleared
    2025-12-18

    (92 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    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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    K Number
    K253758

    Validate with FDA (Live)

    Device Name
    Dental Cone; Dental Sponge
    Manufacturer
    Medizin Produkte Neustadt GmbH (Mpn)
    Date Cleared
    2025-12-18

    (23 days)

    Product Code
    OLR
    Regulation Number
    N/A
    Type
    Special
    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
    K252320

    Validate with FDA (Live)

    Device Name
    SIMDA Abutments
    Manufacturer
    Simda Co., Ltd.
    Date Cleared
    2025-12-18

    (146 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    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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    K Number
    K252785

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    Device Name
    TopCEM Vigor SA Self-Adhesive Resin Cement
    Manufacturer
    Rizhao Huge Biomaterials Company, Ltd.
    Date Cleared
    2025-12-12

    (101 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    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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    K Number
    K252090

    Validate with FDA (Live)

    Device Name
    Pterygoid Indication for GM Helix Implants
    Manufacturer
    JJGC Indústria e Comércio de Materiais Dentários S.A.
    Date Cleared
    2025-12-12

    (163 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    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
    K242817

    Validate with FDA (Live)

    Device Name
    Jason membrane
    Manufacturer
    Botiss Biomaterials GmbH
    Date Cleared
    2025-12-12

    (450 days)

    Product Code
    NPL
    Regulation Number
    872.3930
    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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    K Number
    K252343

    Validate with FDA (Live)

    Device Name
    Atlantis® Abutments in Titanium
    Manufacturer
    Dentsply Sirona
    Date Cleared
    2025-12-09

    (134 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    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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    K Number
    K252808

    Validate with FDA (Live)

    Device Name
    GlasIonomer FX-LC
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2025-12-09

    (97 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    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
    AI/ML Overview
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