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

    AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE

    K Number: K040548 · Decision Mar 19, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    192
    Applicant Total
    45
    Review Days
    17

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    Basic Information

    Device Name
    AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE
    K Number
    K040548
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3750
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Harry J. Bosworth Co.
    Date Received
    March 2, 2004
    Decision Date
    March 19, 2004
    Product Code
    DYH
    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
    DYH Adhesive, Bracket And Tooth Conditioner, Resin

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    Other Clearances by Harry J. Bosworth Co.

    K Number Device Name
    K103585 BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP
    K100731 BOSWORTH AIR POLISHER
    K061611 BOSWORTH DENTIN RESIN
    K051224 BOSWORTH SEAL
    K043170 BOSWORTH BOND
    K040547 AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE
    K033751 AEGIS PIT & FISSURE SEALANT WITH ACP
    K031439 ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)
    K031811 PIT & FISSURE SEALANT WITH FLUORIDE
    K994027 ACTIVATOR PASTE
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