AccessGUDID - DEVICE: JJ CARE (15060988910045)

GUDID

Device Identifier (DI) Information

Brand Name: JJ CARE
Version or Model: 30023
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Jack Jack LLC

Primary DI Number: 15060988910045
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052514128 *Terms of Use

Device Description: JJ CARE Temporary Tooth Cement- Zinc Oxide Eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

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:	No
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?
62200	Zinc oxide eugenol dental cement	A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between eugenol and zinc oxide (ZnO). It typically includes some additional fillers/components. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMB	Zinc Oxide Eugenol

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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
Device Size Text, specify: 30g Powder and 15ml Liquid

Device Record Status

Public Device Record Key: e8a63c0d-f370-40ac-9d11-dcee8993e346
Public Version Date: March 18, 2025
Public Version Number: 2
DI Record Publish Date: July 15, 2023