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510(k) Data Aggregation
K Number
K150571Device Name
3i T3 Short Implants
Manufacturer
BIOMET3I
Date Cleared
2015-11-20
(259 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
BIOMET3I
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3i T3® Short Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
Device Description
The 3i T3® Short Implants are manufactured from commercially pure titanium and feature a roughened apex and traditional OSSEOTITE® coronal surface. In addition, the implants are offered with or without a nano-scale discrete crystalline deposition (DCD®) calcium phosphate (CaP) surface treatment. The dental implants are basic screw-type designs available in parallel walled body geometries with an external hex connection for mating with associated Biomet 3t" external connection restorative components. The implants are offered in 5.0mm and 6.0 mm diameters and 5.0mm and 6.0mm lengths to accommodate varying patient anatomy. Size appropriate cover screws are provided with each implant.
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