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

    ADD-ON CONDYLE

    K Number: K002790 · Decision Aug 6, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    6
    Applicant Total
    56
    Review Days
    333

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    Basic Information

    Device Name
    ADD-ON CONDYLE
    K Number
    K002790
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Walter Lorenz Surgical, Inc.
    Date Received
    September 7, 2000
    Decision Date
    August 6, 2001
    Product Code
    NEI
    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
    NEI Prosthesis, Condyle, Mandibular, Temporary

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    Other Clearances by Walter Lorenz Surgical, Inc.

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    K063506 LORENZ STERNAL CLOSURE SYSTEM
    K062842 TWIST DRILL
    K061384 LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM
    K042516 OTOMIMIX
    K030425 LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER
    K040990 MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS
    K040983 LORENZ SELF-DRILLING IMF SCREW
    K033740 LORENZ STERNAL CLOSURE SYSTEM
    Search all 56 clearances from Walter Lorenz Surgical, Inc. →