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510(k) Data Aggregation

    K Number
    K142211
    Device Name
    OT EQUATOR
    Manufacturer
    Rhein '83 SRL
    Date Cleared
    2015-11-25

    (470 days)

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

    Rhein '83 SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla. The OT Equator abutments are indicated for use with the implant systems listed in Attachment B.
    Device Description
    The OT Equator Implant Anchor abutment for endosseous dental implants is appropriate for use with overdentures or partial denture retained in whole or in part by endosseous implants in the mandibula or maxilla. OT Equator technology represents a prosthetic abutment solution for "overdenture". The sphere The emerging profile, specifically designed to accommodate the relative interchangeable copings OT Equator, allows the coupling with a removable prosthesis or "overdenture", which is properly built only if it is properly profiled and based on the patient's gingival arch. Therefore, the removable prosthesis unloads the chewer loads on the natural gum of the intra oral arch, making the OT Equator abutments passive with lacking of solicitation. The OT Equator is manufactured of titanium Ti-6AI-4V (meets ASTM Standard F-136) and it is designed to retain any prosthetic restoration. The OT Equator overdenture system is comprised of a semispherical head, a base, and a screw.
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