BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    SONIC AIR MM1500 + (MID), MODEL 50400014

    K Number: K081268 · Decision Aug 10, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    194
    Applicant Total
    11
    Review Days
    462

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    Basic Information

    Device Name
    SONIC AIR MM1500 + (MID), MODEL 50400014
    K Number
    K081268
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Micro-Mega Societe Anonyme
    Date Received
    May 5, 2008
    Decision Date
    August 10, 2009
    Product Code
    ELC
    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
    ELC Scaler, Ultrasonic

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    Other Clearances by Micro-Mega Societe Anonyme

    K Number Device Name
    K123276 MM-SEAL
    K103123 APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES)
    K042171 AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232
    K971350 SERIES XE, SERIES SE, SERIES TE
    K961275 SIRIUS 10, 10L, 40, 40L
    K961235 SIRIUS 180, 180L, 230, 230L
    K961494 SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE
    K961076 MM 324
    K950555 J SINGLE USE HEAD AND JD REUSABLE HANDLE
    K951272 RELACS 7000
    Search all 11 clearances from Micro-Mega Societe Anonyme →