BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Striate+™

    K Number: K201241 · Decision Jan 11, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    56
    Applicant Total
    2
    Review Days
    248

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    Basic Information

    Device Name
    Striate+™
    K Number
    K201241
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthocell, Ltd.
    Date Received
    May 8, 2020
    Decision Date
    January 11, 2021
    Product Code
    NPL
    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
    NPL Barrier, Animal Source, Intraoral

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    Other Clearances by Orthocell, Ltd.

    K Number Device Name
    K243889 Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)