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510(k) Data Aggregation
K Number
K103280Device Name
BHDENTAL IMPLANT SYSTEM
Manufacturer
BHDENTAL LTD
Date Cleared
2011-02-24
(111 days)
Product Code
NHA, DZE
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
BHDENTAL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BHdental 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 BHdental Implant System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
The BHdental Implant System consists of one and two stage endosseous form dental implant, internal and external hexagonal; internal octagonal; cover screws and healing caps; abutment systems, superstructures and surgical instruments.
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