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

    BOSWORTH AIR POLISHER

    K Number: K100731 · Decision Dec 3, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    45
    Review Days
    263

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    Basic Information

    Device Name
    BOSWORTH AIR POLISHER
    K Number
    K100731
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Harry J. Bosworth Co.
    Date Received
    March 15, 2010
    Decision Date
    December 3, 2010
    Product Code
    EFB
    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
    EFB Handpiece, Air-Powered, Dental

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    Other Clearances by Harry J. Bosworth Co.

    K Number Device Name
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    K040548 AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE
    K040547 AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE
    K033751 AEGIS PIT & FISSURE SEALANT WITH ACP
    K031439 ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)
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