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510(k) Data Aggregation

    K Number
    K240977
    Device Name
    DenQ Sub SLA Implant System
    Manufacturer
    Date Cleared
    2024-09-13

    (156 days)

    Product Code
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DenQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DenQ Sub SLA Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
    Device Description
    The DenQ Sub SLA Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, tapered with straight body and bone level that are similar to other commercial available products based on the intended use, technology used, the material composition employed and performance characteristics. This DenQ Sub SLA fixture of implant system is supplied sterile. The DenQ Sub Abutments are device made of cp titanium grade 4 and titanium alloy intended for use as a Prosthetic restoration. It consists of Abutments(Healing, Solid, Cement, Angled, Temporary, Multi-unit Straight, Multi-unit Angled, Multi-unit Healing Cap, Multiunit Ti Cylinder, Multi-unit Temporary Cylinder and FreeMilling).
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