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

    REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE

    K Number: K023952 · Decision Jan 16, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    31
    Review Days
    50

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    Basic Information

    Device Name
    REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE
    K Number
    K023952
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nobel Biocare Uas, Inc.
    Date Received
    November 27, 2002
    Decision Date
    January 16, 2003
    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 Nobel Biocare Uas, Inc.

    K Number Device Name
    K050444 NOBELREPLACE ADAPTER, MODEL 32412
    K042658 PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004
    K041661 NOBEL BIOCARE ENDOSSEOUS IMPLANTS
    K041876 NOBELDIRECT OD IMPLANT
    K041312 NOBELRONDO DENTAL CERAMIC-ALUMINA
    K041275 PROCERA ABUTMENT OCTAGON
    K040573 NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236
    K033724 NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236
    K031345 NOBEL DIRECT, MODELS 30937, 30938
    K030257 NOBEL PERFECT IMPLANT SYSTEM
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