AccessGUDID - DEVICE: UltraPrint-Dental Temp C&B UV (00850026127034)

GUDID

Device Identifier (DI) Information

Brand Name: UltraPrint-Dental Temp C&B UV
Version or Model: 1.0
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Heygears Inc.

Primary DI Number: 00850026127034
Issuing Agency: GS1
Commercial Distribution End Date: January 12, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 111627614 *Terms of Use

Device Description: 500g, UltraPrint-Dental Temp C&B UV-A2

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?
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBG	Crown And Bridge, Temporary, Resin

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: 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
No Device Sizes

Device Record Status

Public Device Record Key: abbaa8b9-dfa3-497c-b2b2-99a93243256b
Public Version Date: November 01, 2023
Public Version Number: 4
DI Record Publish Date: January 12, 2021