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510(k) Data Aggregation

    K Number
    K203309
    Device Name
    NUVO CF Implant System
    Manufacturer
    JJGC Indústria e Comércio de Materiais Dentários SA
    Date Cleared
    2021-07-06

    (238 days)

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

    JJGC Indústria e Comércio de Materiais Dentários SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. The Attachment Equator abutments are indicated for the attachment of full or partial dentures to NUVO implants. The Attachment Removable Prosthesis abutments are indicated for the attachment of full or partial dentures to Nuvo implants. The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months. CF Titanium Base for Crown is a titanium abutment placed onto dental implants to provide support for customized prosthetic restorations, as copings or crowns. It is indicated for single-unit restorations, cement-retained or screwretained in aesthetic areas on implants installed in the maxilla or mandible. All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. CF Titanium Base for Bridge is a titanium abutment placed onto dental implants to provide support for customized prosthetic restorations. The CF Titanium Base for Bridge is indicated for cement or screw-retained multi-unit restorations. All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. The CARES® Abutment CF is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations (copings or crowns). It is indicated for screw-retained or cement-retained single-unit restorations. All digitally designed abutments for use with the CARES® Abutment are intended to be sent to Straumann for manufacturing at a validated milling center.
    Device Description
    The NUVO CF Implant System includes Implants, Cover Screws, and Abutments. Implants are intended for single use, provided sterile via gamma irradiation, manufactured of commercially pure titanium (Grade 4), have a bone level design, apically tapered thread-form with apical cutting flutes, and an internal hexagonal implant-to-abutment interface. Cover Screws are intended for single use, used to protect the internal geometry of the implants during healing, placed out of occlusion, provided sterile via gamma irradiation or ethylene oxide gas, manufactured of titanium alloy (Ti6Al4V-ELI), and have an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants. Abutments are intended for single use, provided sterile via ethylene oxide gas (except Cobalt-Chromium UCLA CF and CARES Abutment CF which are non-sterile and must be sterilized before use), manufactured of titanium alloy (Ti6Al4V-ELI) or a combination of POM polymer and cobalt-chromium alloy (CoCr), have a conical format in different diameters, height of cementable area and gingival height, are screw-retained to the implant, provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants, and provided with coronal geometries in rotational (non-indexed) and anti-rotational (indexed) versions.
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