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    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

    BTI Interna Prosthetic Components

    K Number: K232750 · Decision Dec 8, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    15
    Review Days
    91

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    Basic Information

    Device Name
    BTI Interna Prosthetic Components
    K Number
    K232750
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B.T.I. Biotechnology Institute, Sl.
    Date Received
    September 8, 2023
    Decision Date
    December 8, 2023
    Product Code
    NHA
    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
    NHA Abutment, Implant, Dental, Endosseous

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    Other Clearances by B.T.I. Biotechnology Institute, Sl.

    K Number Device Name
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    K213106 BTI Interna Dental Implant System UnicCa - Prosthetic Components
    K211952 BTI Interna Narrow/Plus Dental Implant System UnicCa
    K202825 BTI Extra-Short Dental Implant System UnicCa
    K173257 BTI Dental Implant System UnicCa
    K151391 BTI Dental Implant System UnicCa
    K091387 BTI DENTAL IMPLANT 5.5-6.5
    K092112 BTI DENTAL IMPLANT TINY 2.5-3.0
    K070533 BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS
    Search all 15 clearances from B.T.I. Biotechnology Institute, Sl. →