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

    A-DEC/W&H ELECTRIC HANDPIECE MOTOR

    K Number: K133776 · Decision May 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    60
    Applicant Total
    69
    Review Days
    167

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    Basic Information

    Device Name
    A-DEC/W&H ELECTRIC HANDPIECE MOTOR
    K Number
    K133776
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    A-Dec, Inc.
    Date Received
    December 12, 2013
    Decision Date
    May 28, 2014
    Product Code
    EBW
    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
    EBW Controller, Foot, Handpiece And Cord

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    Other Clearances by A-Dec, Inc.

    K Number Device Name
    K213932 A-dec 300, A-dec 500
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    K082716 A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43
    K082827 A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT
    K082985 A-DEC 334/335 DELIVERY SYSTEM
    K070663 A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT
    K051657 A-DEC SELF-CONTAINED WATER SYSTEM
    K032757 A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE
    K032756 A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533
    Search all 69 clearances from A-Dec, Inc. →