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510(k) Data Aggregation
K Number
K142211Device Name
OT EQUATOR
Manufacturer
Rhein '83 SRL
Date Cleared
2015-11-25
(470 days)
Product Code
NHA
Regulation Number
872.3630Why 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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