AccessGUDID - DEVICE: Z5m (07640166760092)

GUDID

Device Identifier (DI) Information

Brand Name: Z5m
Version or Model: Z5m-50-11
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: Z5m-50-11
Company Name: Z SYSTEMS USA INCORPORATED

Primary DI Number: 07640166760092
Issuing Agency: GS1
Commercial Distribution End Date: June 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 033691995 *Terms of Use

Device Description: Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-50-11

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:	Yes
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?
55848	Screw endosteal dental implant, one-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 one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) 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 [?]
K120793	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
Outer Diameter: 5 Millimeter
Length: 11 Millimeter

Device Record Status

Public Device Record Key: 2ba8b8f3-a019-4a3c-8414-1bb8f074bcf4
Public Version Date: January 25, 2024
Public Version Number: 5
DI Record Publish Date: August 25, 2015