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

    PURE Ceramic Implants

    K Number: K151328 · Decision Jan 11, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    41
    Review Days
    238

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    Basic Information

    Device Name
    PURE Ceramic Implants
    K Number
    K151328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Straumann USA
    Date Received
    May 18, 2015
    Decision Date
    January 11, 2016
    Product Code
    DZE
    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
    DZE Implant, Endosseous, Root-Form

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    Other Clearances by Straumann USA

    K Number Device Name
    K130808 STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS
    K130724 CODIAGNOSTIX IMPLANT PLANNING SOFTWARE
    K122855 TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS
    K121131 BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM
    K113606 NNC GOLD ABUTMENT FOR BRIDGES
    K113410 NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT
    K113283 NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS
    K112280 STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM
    K111357 STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM
    K111724 STRAUMANN TIBRUSH
    Search all 41 clearances from Straumann USA →