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510(k) Data Aggregation

    K Number
    K131468
    Device Name
    DENRACLE DENTAL ABUTMENT
    Date Cleared
    2014-05-06

    (350 days)

    Product Code
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREEN DENTECH CO LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Denracle Dental Abutment for Osstem GS Implant is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. This device is compatible with the following implant system: OSSTEM GS Fixture System Ø 4.0 mm, Ø 4.5 mm and Ø 5.0 mm.
    Device Description
    Denracle Dental Abutment for Osstem GS Implant are titanium abutments designed to be used in conjunction with specific dental implants utilizing the Dental Abutment screw, which is made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. Denracle Dental Abutment for Osstem GS Implant is compatible with the following implant systems: OSSTEM GS Fixture System 04.0 mm, Ø4,5 and Ø5,0mm.
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