FDA.reportPublic FDA data

WINSIX Implant System

Primary DI
08051511800032
Brand
WINSIX Implant System
Company
BIOSAF IN SRL
Model
K Implant Ø 3.3 x 15 mm
Catalog number
33015K/MRS
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
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133733000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133733000WINSIX Implant SystemBiosaf IN S.R.L.2015-01-28DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08051511800032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051511800032080515118000328051511800032

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA 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
TypeValueUnit
Height15Millimeter
Outer Diameter3.3Millimeter

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 DIBrandModelCatalogPublished
08051511800001WINSIX Implant SystemK Implant Ø 3.3 x 9 mm 33009K/MRS2016-09-20
08051511800018WINSIX Implant SystemK Implant Ø 3.3 x 11 mm 33011K/MRS2016-09-20
08051511800025WINSIX Implant SystemK Implant Ø 3.3 x 13 mm 33013K/MRS2016-09-20
08051511800049WINSIX Implant SystemK Implant Ø 3.8 x 9 mm 38009K/MRS2016-09-20
08051511800056WINSIX Implant SystemK Implant Ø 3.8 x 11 mm 38011K/MRS2016-09-20
08051511800063WINSIX Implant SystemK Implant Ø 3.8 x 13 mm38013K/MRS2016-09-20
08051511800070WINSIX Implant SystemK Implant Ø 3.8 x 15 mm 38015K/MRS2016-09-20
08051511800087WINSIX Implant SystemK Implant Ø 4.5 x 9 mm 45009K/MRS2016-09-20
08051511800094WINSIX Implant SystemK Implant Ø 4.5 x 11 mm 45011K/MRS2016-09-20
08051511800100WINSIX Implant SystemK Implant Ø 4.5 x 13 mm 45013K/MRS2016-09-20
08051511800117WINSIX Implant SystemK Implant Ø 4.5 x 15 mm 45015K/MRS2016-09-20
08051511800124WINSIX Implant SystemK Implant Ø 5.2 x 9 mm 52009K/MRS2016-09-20
08051511800131WINSIX Implant SystemK Implant Ø 5.2 x 11 mm 52011K/MRS2016-09-20
08051511800148WINSIX Implant SystemK Implant Ø 5.2 x 13 mm 52013K/MRS2016-09-20
08051511800155WINSIX Implant SystemK Implant Ø 5.2 x 15 mm52015K/MRS2016-09-20
08051511800162WINSIX Implant SystemK Implant Ø 3.3 x 9 mm 33009K/FCC2016-09-20
08051511800179WINSIX Implant SystemK Implant Ø 3.3 x 11 mm 33011K/FCC2016-09-20
08051511800186WINSIX Implant SystemK Implant Ø 3.3 x 13 mm 33013K/FCC2016-09-20
08051511800193WINSIX Implant SystemK Implant Ø 3.3 x 15 mm 33015K/FCC2016-09-20
08051511800209WINSIX Implant SystemK Implant Ø 3.8 x 9 mm 38009K/FCC2016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532000430Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000447Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000874Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000942Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000959Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002731Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002748Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532037115Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532037122Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049613Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049620Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049637Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049644Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049651Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049668Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532062841Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532036965Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036972Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036989Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532049576ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532049583ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066047ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066054ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532067778ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532067785ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532000928ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532000935ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002649ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002656ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002663ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16