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

    BTI Extra-Short Dental Implant System UnicCa

    K Number: K202825 · Decision Jul 29, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    15
    Review Days
    308

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BTI Extra-Short Dental Implant System UnicCa
    K Number
    K202825
    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
    September 24, 2020
    Decision Date
    July 29, 2021
    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

    Similar 510(k) Clearances

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

    MegaGen Zygoma Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    INOSS System

    FDA 510(k)
    FDA Class 2 ·Dental

    Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant

    FDA 510(k)
    FDA Class 2 ·Dental

    Adin Long Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    ZENEX Implant System_Short (R-System)

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

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

    K Number Device Name
    K240262 BTI Interna 3.0 Dental Implant System UnicCa®
    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
    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. →