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510(k) Data Aggregation
K Number
K073645Device Name
SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM
Manufacturer
659543 BC LTD.
Date Cleared
2008-10-21
(300 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
659543 BC LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INDICATIONS FOR USE: The Transitional Implants are designed for temporary use in edentulous sites. The primary purpose is to provide provisional prosthetic devices to protect the permanent implants from premature loading during the healing period. They are used to support bridges and dentures. Additional uses are inter-radicular transitional applications, immediate splinting stability, full and partial edentulism and using minimally invasive surgical interventions. The target population is determined when there is inadequate bone for wider implants as well as for patients wishing immediate functional loading. The transitionals are to be used in a clinical site by a qualified dentist experienced in placing dental implants.
Device Description
This transitional implant is designed to serve as a provisional artificial root to provide immediate load support for permanent implants. They are manufactured using 6/4 Titanium alloy 90% titanium 6% aluminum and 4 % vanadium for strength. The implants are grit blasted . The diameter is 2.5mm and the Lengths are 10mm,(SM3002, 13mm (SM3003) and 15 mm (SM3004). The implants are designed as one piece with a ball abutment on one end at the top of the implant. The ball fits into a rubber o-ring and keeper in the prosthesis which is designed for retention.
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