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510(k) Data Aggregation

    K Number
    K992582
    Device Name
    PACIFIC IMPLANT TITANIUM ENDODONTIC POINT
    Manufacturer
    PACIFIC IMPLANT, INC.
    Date Cleared
    1999-10-21

    (80 days)

    Product Code
    EKL
    Regulation Number
    872.3840
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACIFIC IMPLANT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pacific Implant Titanium Endodontic Point is intended for use during endodontic therapy to fill permanently the root canal of a tooth.
    Device Description
    The product is a titanium endodontic point having the same intended use as endodontic silver points; i.e. to be used during endodontic therapy to fill permanently the root canal of a tooth. The device is fabricated in various endodontic point sizes of titanium CP meeting the ASTM F 67 standard specification for unalloyed titanium for surgical implant applications.
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