BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    S-53 INTRORAL DENTAL SYSTEM

    K Number: K962979 · Decision Sep 25, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    12
    Applicant Total
    7
    Review Days
    56

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    Basic Information

    Device Name
    S-53 INTRORAL DENTAL SYSTEM
    K Number
    K962979
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4130
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Del Medical Systems Corp.
    Date Received
    July 31, 1996
    Decision Date
    September 25, 1996
    Product Code
    DZA
    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
    DZA Drill, Dental, Intraoral

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