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

    CARERITE BIOPACK GINGIVAL RETRACTION CORD

    K Number: K871736 · Decision May 27, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    335
    Registration Numbers
    336
    Same Product Code
    61
    Applicant Total
    7
    Review Days
    22

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    Basic Information

    Device Name
    CARERITE BIOPACK GINGIVAL RETRACTION CORD
    K Number
    K871736
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6390
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Cost Rite Health Products, Inc.
    Date Received
    May 5, 1987
    Decision Date
    May 27, 1987
    Product Code
    JES
    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
    JES Floss, Dental

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    Other Clearances by Cost Rite Health Products, Inc.

    K Number Device Name
    K891141 CARERITE FACE MASK
    K890667 RUBBER DAM
    K873705 CARERITE FACE MASK
    K871798 FILM AND PAPER COMBINATION STERILIZING BAG
    K870147 CARERITE & COST RITE NYLON STERILIZATION FILM
    K870906 CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 4500