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510(k) Data Aggregation
K Number
K051859Device Name
SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEM
Manufacturer
SIN SISTEMA DE IMPLANTE NACIONAL LTDA
Date Cleared
2005-09-23
(77 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SIN SISTEMA DE IMPLANTE NACIONAL LTDA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sistema de Implante Nacional Dental Implant System is intended to be surqically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Restorations supported by two or more Sistema de Implante Nacional implants may be loaded immediately after implant placement if primary implant stability has been achieved.
Device Description
Sistema de Implante Nacional Dental Implants are threaded, tapered and straight endosseous dental implants made of commercially pure titanium and intended for use with Sistema de Implante Nacional System abutments and instruments. The implants are offered in a multiple of lengths and diameters. They are offered with a machined surface or acid etched.
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