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510(k) Data Aggregation

    K Number
    K030161
    Device Name
    SUPERBOND
    Manufacturer
    AMERICAN DENT-ALL, INC.
    Date Cleared
    2003-03-17

    (60 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DENT-ALL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Superbond (Ceramic Dental Casting Alloy) is for the use in Dental Laboratories, suitable for use in fabrication of metal-ceramic dental restoration.
    Device Description
    Not Found
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    K Number
    K011706
    Device Name
    FLEXICAST PRIME
    Manufacturer
    AMERICAN DENT-ALL, INC.
    Date Cleared
    2001-08-06

    (63 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DENT-ALL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Flexicast Prime ( Partial Denture Dental Casting Alloy ) is for use in dental laboratories, suitable for preparation of removable dental appliances.
    Device Description
    Flexicast Prime ( Partial Denture Dental Casting Alloy )
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    K Number
    K011705
    Device Name
    SUPREMCAST
    Manufacturer
    AMERICAN DENT-ALL, INC.
    Date Cleared
    2001-08-03

    (60 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DENT-ALL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Supremcast Alloy is a Dental Ceramic Casting Alloy. For use in dental laboratories. Suitable for use in fabrication of ceramic fused to metal Dental restoration.
    Device Description
    Supremcast Alloy is a Dental Ceramic Casting Alloy.
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    K Number
    K003509
    Device Name
    FLEXICAST
    Manufacturer
    AMERICAN DENT-ALL, INC.
    Date Cleared
    2001-01-02

    (49 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DENT-ALL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001383
    Device Name
    SUPREMCAST V
    Manufacturer
    AMERICAN DENT-ALL, INC.
    Date Cleared
    2000-07-05

    (64 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DENT-ALL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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