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510(k) Data Aggregation

    K Number
    K982201
    Device Name
    ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)
    Manufacturer
    FOREMOST DENTAL MFG., INC.
    Date Cleared
    1998-08-10

    (49 days)

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

    FOREMOST DENTAL MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Core material- when a tooth is fractured a Technique called Post and core is used to restore functum. A post is cemented into the endo dentically Treated tooth. A core material is used to build up around the tooth and post so that a finished appliance can be placed.
    Device Description
    Not Found
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    K Number
    K981813
    Device Name
    PERMACEM AUTOMIX LUTING CEMENT SYSTEM
    Manufacturer
    FOREMOST DENTAL MFG., INC.
    Date Cleared
    1998-07-10

    (49 days)

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

    FOREMOST DENTAL MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PermaCem® is a compomer based permanent luting cement to be applied by the dental professional prior to the cementation of crowns, bridges, inlays, onlays and veneers in patients.
    Device Description
    Not Found
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    K Number
    K980963
    Device Name
    HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)
    Manufacturer
    FOREMOST DENTAL MFG., INC.
    Date Cleared
    1998-05-11

    (56 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOREMOST DENTAL MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Honigum® Automix and Honigum® Quick are polysiloxane impression materials to be applied by the dental professional prior to fabrication of crowns, bridges and inlays for their patients.
    Device Description
    polysiloxane impression materials
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    K Number
    K970683
    Device Name
    ZENTIH FLOWABLE COMPOSITE (MULTIPLE)
    Manufacturer
    FOREMOST DENTAL MFG., INC.
    Date Cleared
    1997-07-15

    (141 days)

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

    FOREMOST DENTAL MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zenith Flowable Composite is a tooth-shaded resin filling material for use as an esthetic anterior restoration or mase restoration under posterior or anterior composites.
    Device Description
    Zenith Flowable Composite is a tooth-shaded resin filling material.
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    K Number
    K970774
    Device Name
    TEMPOCEM NE (MULTIPLE)
    Manufacturer
    FOREMOST DENTAL MFG., INC.
    Date Cleared
    1997-06-03

    (91 days)

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

    FOREMOST DENTAL MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TempoCem N/E is a dental luting agent for the temporary cementation of crowns and bridges.
    Device Description
    Not Found
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    K Number
    K970775
    Device Name
    TEMPO CEM (MULTIPLE)
    Manufacturer
    FOREMOST DENTAL MFG., INC.
    Date Cleared
    1997-06-03

    (91 days)

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

    FOREMOST DENTAL MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TempoCem is a dental luting agent for the temporary cementation of provisional crowns and bridges.
    Device Description
    Not Found
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    K Number
    K954867
    Device Name
    IONOSIT SEAL
    Manufacturer
    FOREMOST DENTAL MFG., INC.
    Date Cleared
    1996-03-08

    (136 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOREMOST DENTAL MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ionosit Seal is a dental pit and fissure sealant intended to be used to seal the pits and fissures of occlusual non-carious posterior teeth.
    Device Description
    A one-component light cured liquid resin. Lightly filled with a fluoride containing glass powder.
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