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510(k) Data Aggregation
K Number
K160060Device Name
DMi Dental Implant System
Manufacturer
Date Cleared
2016-10-03
(265 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
DMi Innovative Medical Technology Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DMi Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient chewing function.
The DMi Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading
Device Description
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