AccessGUDID - DEVICE: WINSIX Implant System (08051511800186)

GUDID

Device Identifier (DI) Information

Brand Name: WINSIX Implant System
Version or Model: K Implant Ø 3.3 x 13 mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 33013K/FCC
Company Name: BIOSAF IN SRL

Primary DI Number: 08051511800186
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428657609 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55847	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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DZE	Implant, Endosseous, Root-Form

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133733	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Height: 13 Millimeter
Outer Diameter: 3.3 Millimeter

Device Record Status

Public Device Record Key: e3575e34-10b6-4324-95ce-5cd05e4dda2b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016