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

    SATALEC SERVOTOME

    K Number: K852522 · Decision Dec 27, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    18
    Applicant Total
    11
    Review Days
    196

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    Basic Information

    Device Name
    SATALEC SERVOTOME
    K Number
    K852522
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4920
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Spelna, Inc.
    Date Received
    June 14, 1985
    Decision Date
    December 27, 1985
    Product Code
    EKZ
    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
    EKZ Unit, Electrosurgical, And Accessories, Dental

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    Other Clearances by Spelna, Inc.

    K Number Device Name
    K852525 SATALEC PIEZOTEC
    K852527 SATALEC SEPTOSONIC SC 80/SC 120
    K853200 5X2 SATALEC CHIROPODY CASE
    K852524 SATALEC SERVOTORQUE S2 SX2
    K852521 SATLEC PROPHY UNIT PU 3055
    K832674 SATELEC PROPHY UNIT PU 2000S
    K832664 SATELEC SUPRASSON PIEZOMATIC P2
    K832673 SATELEC PROPHY UNIT PU-2000
    K832665 SATELEC SUPRASSON SP 3055
    K820256 MEDILAC #SR4 & SR 40
    Search all 11 clearances from Spelna, Inc. →