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

    IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES

    K Number: K982492 · Decision Oct 15, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    7
    Review Days
    90

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    Basic Information

    Device Name
    IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES
    K Number
    K982492
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Imcor
    Date Received
    July 17, 1998
    Decision Date
    October 15, 1998
    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 Imcor

    K Number Device Name
    K992512 ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA
    K983563 IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM SELF-TAPPING HA COASTED LOCKTITE IMPLANTS, AND I
    K974126 IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS WITH COVER SCREW
    K973049 IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM
    K960899 IMCOR 5.00 MM HEX SELF-TAPPING SCREW W/COVER SCREW
    K960900 IMCOR 3.75 MM WIDE HEX SELF-TAPPING SCREW W/COVER SCREW