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

    HAND INSTRUMENT CALCULUS REMOVAL

    K Number: K925312 · Decision May 23, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    10
    Review Days
    579

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    Basic Information

    Device Name
    HAND INSTRUMENT CALCULUS REMOVAL
    K Number
    K925312
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Implant Support Systems, Inc.
    Date Received
    October 21, 1992
    Decision Date
    May 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 Implant Support Systems, Inc.

    K Number Device Name
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    K925313 TITANIUM COC ABUTMENT HEADS FOR IMZ
    K925349 ONE SYSTEM TAPERED TITANIUM ABUTMENTS
    K924190 ISS O-RING ATTACHMENT
    K921764 DALLA BONA BALL & SOCKEY ATTACH. SNAP TYPE PRECIS
    K904605 TITANIUM COC ABUTMENT HEADS FOR IMZ
    K895986 PRECISION DENTAL ATTACHMENTS
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