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

    WIDE SCREW HA-5B, CYL-HA-5

    K Number: K952991 · Decision Oct 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    20
    Review Days
    130

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    Basic Information

    Device Name
    WIDE SCREW HA-5B, CYL-HA-5
    K Number
    K952991
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Implant Center of the Palm Beaches
    Date Received
    June 23, 1995
    Decision Date
    October 31, 1995
    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 Implant Center of the Palm Beaches

    K Number Device Name
    K952997 PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED
    K953001 TP-4K SCREW IMPLANT 3.3, 3.75, 4.0
    K953000 WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MM
    K952996 HA/TP COATED CYLINDER IMPLANT 3.3,4.0
    K952992 PROSTHETICS 4MM
    K952994 TP-4 WIDE CYLINDER IMPLANTS
    K952999 UNCOATED SCREW IMPLANT 3.75, 4.0-B5
    K952985 WIDE SCREWS TP-5B. PROS G5, TOOLS G5 OR 17-4 SS
    K952998 TP SCREW IMPLANT 3.75, 4.0-B5
    K953281 HA, TP CYLINDER OVAL
    Search all 20 clearances from Implant Center of the Palm Beaches →