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510(k) Data Aggregation
K Number
K171179Device Name
BR Type Implant System
Manufacturer
Date Cleared
2018-02-09
(291 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Biotem Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BR Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. BR Type Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
Device Description
The BR Implant System is a dental implant system made of CP Ti Gr 4 / ASTM F67, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The surface of the implants has been treated with R.B.M (Resorbable Blast Media) with acid etch. The BR Type Implant System is offered in the following sizes. Each product line includes corresponding abutments in multiple designs (Cover Screws, Healing Abutments, Angled Abutments, Cemented Abutments (Hex, Non-hex), and Solid Abutments) for restorations. Small diameter implants and angled abutments are not recommended for the posterior region. They are made of Titanium Grade 4 / ASTM F67, and provided as non-sterile.
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