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510(k) Data Aggregation
K Number
K161743Device Name
Etgar Dental Implant System
Manufacturer
Date Cleared
2017-04-14
(294 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
ETGAR MEDICAL INSTRUMENTS, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended to replace one or more missing teeth in the upper or lower jaw in partially or fully edentulous patients in order to restore chewing function. Intended to support single or multiple tooth prostheses can be screwed or cement retained to the abutment. Intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
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