AccessGUDID - DEVICE: Neodent (07899878052913)

GUDID

Device Identifier (DI) Information

Brand Name: Neodent
Version or Model: 138.108
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 138.108
Company Name: JJGC Indústria e Comércio de Materiais Dentários S/A.

Primary DI Number: 07899878052913
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 906713888 *Terms of Use

Device Description: EASY PACK HELIX GM ACQUA 3.5X13/SMART ABUTMENT 4.5X3.5

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?
65059	Dental implant kit	A collection of prefabricated dental devices and components, which includes a dental implant, intended to be used during dental surgery and laboratory procedures to create and implant the foundation of a reconstructed tooth. In addition to the dental implant, it includes a dental abutment(s) (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), and additional components to facilitate restoration (e.g., abutment analog, abutment impression cap). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZE	IMPLANT, ENDOSSEOUS, ROOT-FORM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: Room temperature

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 3.5 Millimeter

Device Record Status

Public Device Record Key: dd64a554-ac5d-4827-971c-99b56817dc34
Public Version Date: January 03, 2024
Public Version Number: 2
DI Record Publish Date: March 24, 2021