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

    S & C -BRACKET ADHESIVES

    K Number: K031420 · Decision Aug 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    192
    Applicant Total
    20
    Review Days
    107

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    Basic Information

    Device Name
    S & C -BRACKET ADHESIVES
    K Number
    K031420
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3750
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    S & C Polymer GmbH
    Date Received
    May 5, 2003
    Decision Date
    August 20, 2003
    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 S & C Polymer GmbH

    K Number Device Name
    K091735 DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT
    K083062 ROOT CANAL XR
    K083766 PHOGLASS CEM
    K082115 PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT
    K081702 CARBOXYLATE CEM, PHOSPHATE CEM
    K042614 S&C-SELF ETCH PR-BOND
    K012767 S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL
    K011277 HARD RELINER
    K011431 RESIN CEM
    K011064 CLASSIC CEM
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