FDA.reportPublic FDA data

WINSIX Implant System: Extreme Abutment System

Primary DI
08051511803156
Brand
WINSIX Implant System: Extreme Abutment System
Company
BIOSAF IN SRL
Model
Straight Abutment EA Ø 4.5 GH 1 mm
Catalog number
EA45001
Device description
The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). ABUTMENTS are used for creation of screwed temporary or fixed elements. They have different features to allow the physician to adapt to the different anatomical situation.
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

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
08051511803156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051511803156080515118031568051511803156

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
Height1Millimeter
Outer Diameter4.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
428657609
Device count
1
Lot or batch
true
Sterilization required before use
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
08051511800032WINSIX Implant SystemK Implant Ø 3.3 x 15 mm 33015K/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

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