BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PITT-EASY DENTAL IMPLANT SYSTEM

    K Number: K053242 · Decision Jan 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    4
    Review Days
    49

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    Basic Information

    Device Name
    PITT-EASY DENTAL IMPLANT SYSTEM
    K Number
    K053242
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innova Life Sciences Corp.
    Date Received
    November 18, 2005
    Decision Date
    January 6, 2006
    Product Code
    DZE
    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
    DZE Implant, Endosseous, Root-Form

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    Other Clearances by Innova Life Sciences Corp.

    K Number Device Name
    K052951 ENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM
    K043190 SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
    K032140 5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM