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510(k) Data Aggregation
K Number
K133733Device Name
WINSIX Implant System
Manufacturer
Date Cleared
2015-01-28
(418 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
BIOSAF IN S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
WINSIX Implant System is indicated for single or multiple tooth replacement, or for use in terminal intermediate edentulous sites in the mandible and/or the maxilla, and for totally edentulous arches. The system is designed to be surgically inserted in the bone structure of the mouth in order to replace missing teeth. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
The family of WINSIX Implant System is intended for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. The family of WINSIX Implant Systems can also be used for immediate or early load implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single tooth and/or appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). The family of WINSIX Implant System includes the following devices: Fixtures and Abutments. The fixtures are the endosseous dental implantable devices produced in commercially pure titanium (grade 4), available in following models: K Model, KT Model, Conical Model, TTi Model with various diameters and lengths in order to meet diverse anatomical requirements. They are single use devices, supplied sterile and cannot be re-sterilised. The abutments give at the physician a complete prosthetic solutions in order to use the WINSIX implant system as intended. They have been divided in followings main groups: COVER SCREWS, HEALING SREWS, and ABUTMENTS (straight, angulated, millable, and flat shift).
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