LogoFDA 510(k) Search
Search Filters

Search Results

Found 36 results

510(k) Data Aggregation

    K Number
    K251470
    Device Name
    ResiCem EX
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2025-07-11

    (59 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shofu Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K251578
    Device Name
    BEAUTIFIL II
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2025-05-27

    (5 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shofu Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Anterior and posterior restorations - Repair of restorations and prostheses - Core-build up - Direct laminate veneer
    Device Description
    Not Found
    Ask a Question
    K Number
    K233161
    Device Name
    BeautiLink SA
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2023-09-28

    (1 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shofu Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cementation of all-ceramic, composite and metal restorations Post cementation
    Device Description
    Not Found
    Ask a Question
    K Number
    K222253
    Device Name
    GlasIonomer FX ULTRA
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2022-09-22

    (57 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shofu Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Restoration of deciduous teeth - Non-load bearing Class I and Class II restorations in permanent teeth - Restoration of Class III and Class V cavities and wedge shaped defects - Core build-up
    Device Description
    Not Found
    Ask a Question
    K Number
    K212939
    Device Name
    Vintage Prime Press
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2022-03-18

    (184 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shofu Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fabrication of all ceramic restorations except for four- or more unit bridges including molars.
    Device Description
    Not Found
    Ask a Question
    K Number
    K213965
    Device Name
    BeautiBond Xtreme
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2022-03-18

    (88 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shofu Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Direct restorations with light-cured composite resin - Repair of fractured restorations with light-cured composite resin - Post cementation and core build-up - Cementation of indirect restorations with light-cured/dual-cured resin cement - Treatment of hypersensitive teeth or exposed root surface - Sealing of tooth preparation (cavity or abutment) for indirect restorations
    Device Description
    Not Found
    Ask a Question
    K Number
    K200470
    Device Name
    Shofu Block HC Hard
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2021-02-05

    (345 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shofu Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations and implant supported restorations, using a dental CAD / CAM system.
    Device Description
    Not Found
    Ask a Question
    K Number
    K191794
    Device Name
    Vintage Art Universal
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2019-10-03

    (92 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shofu Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Shade adjustment of ceramic restorations
    Device Description
    Not Found
    Ask a Question
    K Number
    K182869
    Device Name
    Fit SA
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2019-01-09

    (89 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shofu Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Class III and Class V restorations - Small Class I restoration - Base/Liner
    Device Description
    Not Found
    Ask a Question
    K Number
    K181496
    Device Name
    VINTAGE PRO
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2018-12-18

    (194 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shofu Dental Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Build-up porcelain for fabrication of metal bonded ceramic restorations
    Device Description
    Not Found
    Ask a Question

    Page 1 of 4