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

    Titan 3 Low Speed Angle Attachments

    K Number: K162397 · Decision Jan 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    72
    Applicant Total
    7
    Review Days
    146

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    Basic Information

    Device Name
    Titan 3 Low Speed Angle Attachments
    K Number
    K162397
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dentalez, Inc.
    Date Received
    August 26, 2016
    Decision Date
    January 19, 2017
    Product Code
    EGS
    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
    EGS Handpiece, Contra- And Right-Angle Attachment, Dental

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