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

    ASTRON 77 INJECTION DENTURE RESIN

    K Number: K833270 · Decision Jul 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    5
    Review Days
    302

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    Basic Information

    Device Name
    ASTRON 77 INJECTION DENTURE RESIN
    K Number
    K833270
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Astron Dental Corp.
    Date Received
    September 21, 1983
    Decision Date
    July 19, 1984
    Product Code
    EBI
    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
    EBI Resin, Denture, Relining, Repairing, Rebasing

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    Other Clearances by Astron Dental Corp.

    K Number Device Name
    K874025 2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN
    K864757 MODIFIED VINYLAC PRESS PACK DENTURE RESIN
    K852906 DURACLEAN DENTURE CLEANER
    K831269 VINYLAC PRESS-PACK DENTURE RESIN