AccessGUDID - DEVICE: Health-Tec Temporary C&B Material 4:1 (D773110100031)

GUDID

Device Identifier (DI) Information

Brand Name: Health-Tec Temporary C&B Material 4:1
Version or Model: 110-10003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 110-10003
Company Name: Dental Health Products Inc

Primary DI Number: D773110100031
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 623191194 *Terms of Use

Device Description: Health-Tec Temporary C&B Material 4:1, Shade A3.5

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
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?
31783	Temporary dental crown/bridge	A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFH	Paper, Articulation

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
Storage Environment Temperature: between 58 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 50 Milliliter

Device Record Status

Public Device Record Key: c5a38546-bd0e-489b-a8c6-153b8fa385e0
Public Version Date: October 29, 2021
Public Version Number: 3
DI Record Publish Date: January 24, 2017