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

    BTI Dental Implant System UnicCa® – Aesthetic Post Abutments

    K Number: K231827 · Decision Sep 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    390
    Registration Numbers
    390
    Same Product Code
    672
    Applicant Total
    5
    Review Days
    86

    Basic Information

    Device Name
    BTI Dental Implant System UnicCa® – Aesthetic Post Abutments
    K Number
    K231827
    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, S.L.
    Date Received
    June 21, 2023
    Decision Date
    September 15, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NHA), ordered by most recent decision date.

    Sherlock

    FDA 510(k)
    FDA Class 2 ·Dental

    MIST IC

    FDA 510(k)
    FDA Class 2 ·Dental

    Geo Abutment

    FDA 510(k)
    FDA Class 2 ·Dental

    Dynamic TiBase

    FDA 510(k)
    FDA Class 2 ·Dental

    Neodent Implant System - Custom Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    DESS Dental Smart Solutions

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by B.T.I. Biotechnology Institute, S.L.

    K Number Device Name
    K240262 BTI Interna 3.0 Dental Implant System UnicCa®
    K232750 BTI Interna Prosthetic Components
    K202825 BTI Extra-Short Dental Implant System UnicCa
    K173257 BTI Dental Implant System UnicCa