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

    PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO

    K Number: K926101 · Decision Jun 23, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    5
    Review Days
    567

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    Basic Information

    Device Name
    PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO
    K Number
    K926101
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Phoenix Dental, Inc.
    Date Received
    December 3, 1992
    Decision Date
    June 23, 1994
    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 Phoenix Dental, Inc.

    K Number Device Name
    K120109 SUPER SEAL TOOTH DESENSITIZER
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    K983477 SUPER SEAL
    K926102 PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN