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510(k) Data Aggregation

    K Number
    K251427

    Validate with FDA (Live)

    Device Name
    EK MULTI ANGLED 30 ABUTMENT
    Manufacturer
    Hiossen, Inc.
    Date Cleared
    2026-01-29

    (266 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K182091,K233194,K203360
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K182091, K233194

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.

    Device Description

    The EK Multi Angled 30 Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients. Manufactured from medical grade titanium alloy and delivered non-sterilized. The EK Multi Angled 30 Abutments are available in various lengths and diameters.

    AI/ML Overview

    N/A

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