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510(k) Data Aggregation
K Number
K070935Device Name
T.B.R. ZIRCONNECT
Manufacturer
Date Cleared
2007-11-09
(220 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SUDIMPLANT SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The T.B.R.® Zirconnect endosseous dental implant is a device intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
Device Description
The T.B.R.® Zirconnect dental implant system consists of root form, screw-type implants (made from Ti-6Al-4V ) and restorative components with many options such as Ti-6Al-4V abutments, conical abutments. castable abutments and ball abutments. The system also includes surgical and laboratory accessories. Implants are double-packaged and provided sterile. Implants surface is roughened to promote osseointegration.
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K Number
K050956Device Name
TBR IDEA CONIC/CONIC
Manufacturer
Date Cleared
2006-02-16
(307 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SUDIMPLANT SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The T.B.R.® ide@ conic endosseous dental implant is a device intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
Device Description
Description of the donic/Conic dental implant system consists of selftapping threaded screw-type implants (made from Ti-6AI-4V ) and tapping througou overs with many options such as Ti-6Al-4V abutments, tapered abutments, castable abutments, ball abutments and ceramic/Titapered abutments. The system also include surgical and laboratory ord av abutiments. Implants are double-packaged and provided sterile. Implants surface is roughened to promote osseointegration.
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