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

    BTI Interna 3.0 Dental Implant System UnicCa®

    K Number: K240262 · Decision Oct 10, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    15
    Review Days
    253

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    Basic Information

    Device Name
    BTI Interna 3.0 Dental Implant System UnicCa®
    K Number
    K240262
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B.T.I. Biotechnology Institute, Sl.
    Date Received
    January 31, 2024
    Decision Date
    October 10, 2024
    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 B.T.I. Biotechnology Institute, Sl.

    K Number Device Name
    K232750 BTI Interna Prosthetic Components
    K231827 BTI Dental Implant System UnicCa® – Aesthetic Post Abutments
    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. →