AccessGUDID - DEVICE: Implantswiss (07640168181925)

GUDID

Device Identifier (DI) Information

Brand Name: Implantswiss
Version or Model: S-TWFHR5512
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S-TWFHR5512
Company Name: Novodent SA

Primary DI Number: 07640168181925
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480055352 *Terms of Use

Device Description: Tissue level Wide Fixture Hybrid SRA 5.5 x 12 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Implant: The part of the system that is inserted in and connected to the jaw bone to allow for prosthesis superstructure fixation, which includes an abutment."

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?
55849	Screw endosteal dental implant, two-piece	A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted 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 is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.	Active	true

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181266	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
Special Storage Condition, Specify: Keep away from light and sun

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e8cedc0b-9ffb-4241-8574-bc45895fa134
Public Version Date: April 13, 2021
Public Version Number: 2
DI Record Publish Date: March 31, 2021