Home GUDID 08051511800223 WINSIX Implant System
Primary DI 08051511800223
Brand WINSIX Implant System
Company BIOSAF IN SRL
Model K Implant Ø 3.8 x 13 mm
Catalog number 38013K/FCC
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. K Implant is a fixture model of WINSIX Implant System.
Published 2016-09-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name DZE Implant, Endosseous, Root-Form
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DZE Implant, Endosseous, Root-Form Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08051511800223 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08051511800223 08051511800223 8051511800223
GMDN Terms# Term, Definition table Term Definition Dental implant system A collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.
Device Sizes# Type, Value, Unit table Type Value Unit Height 13 Millimeter Outer Diameter 3.8 Millimeter
Regulatory Flags# DUNS number 428657609 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08051511800001 WINSIX Implant System K Implant Ø 3.3 x 9 mm 33009K/MRS 2016-09-20 08051511800018 WINSIX Implant System K Implant Ø 3.3 x 11 mm 33011K/MRS 2016-09-20 08051511800025 WINSIX Implant System K Implant Ø 3.3 x 13 mm 33013K/MRS 2016-09-20 08051511800032 WINSIX Implant System K Implant Ø 3.3 x 15 mm 33015K/MRS 2016-09-20 08051511800049 WINSIX Implant System K Implant Ø 3.8 x 9 mm 38009K/MRS 2016-09-20 08051511800056 WINSIX Implant System K Implant Ø 3.8 x 11 mm 38011K/MRS 2016-09-20 08051511800063 WINSIX Implant System K Implant Ø 3.8 x 13 mm 38013K/MRS 2016-09-20 08051511800070 WINSIX Implant System K Implant Ø 3.8 x 15 mm 38015K/MRS 2016-09-20 08051511800087 WINSIX Implant System K Implant Ø 4.5 x 9 mm 45009K/MRS 2016-09-20 08051511800094 WINSIX Implant System K Implant Ø 4.5 x 11 mm 45011K/MRS 2016-09-20 08051511800100 WINSIX Implant System K Implant Ø 4.5 x 13 mm 45013K/MRS 2016-09-20 08051511800117 WINSIX Implant System K Implant Ø 4.5 x 15 mm 45015K/MRS 2016-09-20 08051511800124 WINSIX Implant System K Implant Ø 5.2 x 9 mm 52009K/MRS 2016-09-20 08051511800131 WINSIX Implant System K Implant Ø 5.2 x 11 mm 52011K/MRS 2016-09-20 08051511800148 WINSIX Implant System K Implant Ø 5.2 x 13 mm 52013K/MRS 2016-09-20 08051511800155 WINSIX Implant System K Implant Ø 5.2 x 15 mm 52015K/MRS 2016-09-20 08051511800162 WINSIX Implant System K Implant Ø 3.3 x 9 mm 33009K/FCC 2016-09-20 08051511800179 WINSIX Implant System K Implant Ø 3.3 x 11 mm 33011K/FCC 2016-09-20 08051511800186 WINSIX Implant System K Implant Ø 3.3 x 13 mm 33013K/FCC 2016-09-20 08051511800193 WINSIX Implant System K Implant Ø 3.3 x 15 mm 33015K/FCC 2016-09-20
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