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

    FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE

    K Number: K945847 · Decision Mar 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    4
    Review Days
    471

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    Basic Information

    Device Name
    FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE
    K Number
    K945847
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Friatec Medical Inc., USA
    Date Received
    November 30, 1994
    Decision Date
    March 15, 1996
    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 Friatec Medical Inc., USA

    K Number Device Name
    K945848 FRIALIT(R)-2 DENTAL IMPLANT
    K945849 FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING
    K934332 SURGICAL INSTRUMENTS, FORCEPS & GRASPERS, PROBES & CURETTES