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510(k) Data Aggregation

    K Number
    K011785
    Device Name
    NOVEL PRINT CYAN ALGINATES
    Date Cleared
    2001-09-04

    (88 days)

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

    MANUFACTURERA DENTAL CONTINENTAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide the study and for production of catestication study and for production of restorative prosthetic devices, such as gold inlays and dentures.
    Device Description
    Novel Print Cyan Alginates
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    K Number
    K991577
    Device Name
    NIC TONE ACRYLIC RESINS
    Date Cleared
    1999-09-22

    (139 days)

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

    MANUFACTURERA DENTAL CONTINENTAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Nic Tone Acrylic Resins are used in the fabrication, repair or rebasing of complete or partial removable dentures, the fabrication of veneer crowns, the fabrication of orthodontic devices, and the fabrication of temporary crowns and bridges.
    Device Description
    Not Found
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