BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    HARD RELINER

    K Number: K011277 · Decision Jun 26, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    20
    Review Days
    61

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    Basic Information

    Device Name
    HARD RELINER
    K Number
    K011277
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    S & C Polymer GmbH
    Date Received
    April 26, 2001
    Decision Date
    June 26, 2001
    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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    K042614 S&C-SELF ETCH PR-BOND
    K031420 S & C -BRACKET ADHESIVES
    K012767 S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL
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