AccessGUDID - DEVICE: WINSIX Implant System: Counterbore healing screw internal hex connection (08051511801374)

GUDID

Device Identifier (DI) Information

Brand Name: WINSIX Implant System: Counterbore healing screw internal hex connection
Version or Model: counterbore healing screw Ø 3.3 H 5 mm for internal hex connection
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VG334
Company Name: BIOSAF IN SRL

Primary DI Number: 08051511801374
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428657609 *Terms of Use

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. Healing screws are used to cover the fixtures and to model the mucosa during her healing.

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
NHA	Abutment, Implant, Dental, Endosseous

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Height: 5 Millimeter
Outer Diameter: 3.3 Millimeter

Device Record Status

Public Device Record Key: 96cac7eb-ce1c-4230-9989-14512bdffaee
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016