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510(k) Data Aggregation
K Number
K180968Device Name
AlphaDent Implants Dental Implants System
Manufacturer
AlphaDent Implants Ltd
Date Cleared
2019-07-03
(446 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
AlphaDent Implants Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or mandbular arch, to support crowns, bridges, or over dentures, in edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. The prostheses can be screw or cement retained to the abutment. The Alpha Dent Implants Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
The Alpha Dent Implants Dental Implants System consists of one or two stage endosseous form dental implants, internal hexagonal and one piece implants system. Abutments are used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation. The implantation procedure can be accomplished in a one-stage surgical operation for all implants type beside the INTEGRAL which is for one stage only. The system includes two-piece implant families: Active, Active Plus, and Classic, and a one-piece implant family: Integral. The system also includes prosthetic components such as healing caps, straight and angular abutments, titanium esthetic abutments, multi-unit abutments, ball attachments, and accessories.
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