BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PACIFIC IMPLANT TITANIUM ENDODONTIC POINT

    K Number: K992582 · Decision Oct 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    80

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    Basic Information

    Device Name
    PACIFIC IMPLANT TITANIUM ENDODONTIC POINT
    K Number
    K992582
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3840
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pacific Implant, Inc.
    Date Received
    August 2, 1999
    Decision Date
    October 21, 1999
    Product Code
    EKL
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EKL Point, Silver, Endodontic

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    Other Clearances by Pacific Implant, Inc.

    K Number Device Name
    K813227 INTRAOSSEOUS DENTAL IMPLANT