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510(k) Data Aggregation

    K Number
    K112597
    Device Name
    SEITY 37% PHOSPHORIC ACID ETCHANT GEL
    Manufacturer
    MYCONE DENTAL SUPPLY CO., INC.
    Date Cleared
    2011-12-07

    (91 days)

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

    MYCONE DENTAL SUPPLY CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations.
    Device Description
    Seity 37% Phosphoric Acid Etchant Gel
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    K Number
    K093380
    Device Name
    MIZZY EXPRESS
    Manufacturer
    MYCONE DENTAL SUPPLY CO., INC.
    Date Cleared
    2010-03-05

    (127 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    MYCONE DENTAL SUPPLY CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For fabrication of temporary prostheses, such as crowns or bridges
    Device Description
    Not Found
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    K Number
    K032773
    Device Name
    DIAMOND D HIGH IMPACT DENTURE ACRYLIC
    Manufacturer
    MYCONE DENTAL SUPPLY CO., INC.
    Date Cleared
    2003-09-23

    (15 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    MYCONE DENTAL SUPPLY CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mycone Dental's denture material, known as Diamond D, is intended to form new dentures or to repair fractured dentures. It is to be used only by professional dental practitioners who make or repair dentures for patients.
    Device Description
    Not Found
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    K Number
    K983876
    Device Name
    MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC
    Manufacturer
    MYCONE DENTAL SUPPLY CO., INC. (A/K/A KEYSTONE IND
    Date Cleared
    1998-12-16

    (44 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    MYCONE DENTAL SUPPLY CO., INC. (A/K/A KEYSTONE IND

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The denture materials manufactured by Keystone Industries are intended to be used to form new dentures or to repair fractured dentures. They are to be used only by professional dental practitioners who make or repair dentures for patients.
    Device Description
    Not Found
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