AccessGUDID - DEVICE: MD-Temp(White) (08806387892137)

GUDID

Device Identifier (DI) Information

Brand Name: MD-Temp(White)
Version or Model: 9213
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Meta Biomed Co., Ltd.

Primary DI Number: 08806387892137
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688322841 *Terms of Use

Device Description: MD-Temp is a temporary resin for formation of temporary fillings, and other temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. It is a hydraulic temporary restorative.

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):	No
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?
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
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: a69906f1-37aa-4f1a-afb4-fb6f3fd8253c
Public Version Date: October 29, 2021
Public Version Number: 3
DI Record Publish Date: September 19, 2016