FDA.reportPublic FDA data

WINSIX Implant System: Extreme Abutment System

Primary DI
08051511803064
Brand
WINSIX Implant System: Extreme Abutment System
Company
BIOSAF IN SRL
Model
Straight Abutment EA Ø 3.3 GH 2 mm
Catalog number
EA33002
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
08051511803064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051511803064080515118030648051511803064

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
Height2Millimeter
Outer Diameter3.3Millimeter

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842448118561TITAN IMPLANTS INC.TITAN IMPLANT INCNHA2026-09-06
00810125998713ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998720ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998737ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998744ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998751ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998768ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998775ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998782ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998799ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998805ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998812ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998829ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998836ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998843ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998850ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998867ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998874ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998881ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998898ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998904ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998911ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998928ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998935ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998942ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998959EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998966EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998973EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998980EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998997EK Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04