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510(k) Data Aggregation
K Number
K121281Device Name
SIMPLI SIMPLER IMPLANT SYSTEM
Manufacturer
Date Cleared
2013-04-05
(340 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SIMPLER IMPLANT SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SIMPLI Simpler Implant System is indicated for use in surgical and restorative applications for placement of implants in the mandible and maxilla to provide support for prosthetic devices such as artificial teeth to provide chewing function to a patient with missing teeth. It is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
The SIMPLI™ Simpler implant system is a threaded, endosseous dental implant designed to be one piece immediate load as well as delayed load to replace one, several or all missing teeth.
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