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510(k) Data Aggregation

    K Number
    K122852
    Device Name
    PHYSIOSTAR NFC
    Manufacturer
    CANDULOR USA, INC.
    Date Cleared
    2012-12-06

    (79 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Applicant Name (Manufacturer) :

    CANDULOR USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Physiostar NFC denture teeth are intended to be used for complete and partial denture r nyslostar NF & dontare tooling and implant-supported dentures.
    Device Description
    Not Found
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    K Number
    K101814
    Device Name
    DIRECT CROWN NATURAL 1
    Manufacturer
    CANDULOR USA, INC.
    Date Cleared
    2010-09-27

    (90 days)

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

    CANDULOR USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Direct Crown Natural 1 is intended for the fabrication of short and long term temporary crowns and bridges (up to 12 months) using the Direct Crown shell teeth.
    Device Description
    Not Found
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