AccessGUDID - DEVICE: Synthetic Polymer Teeth (06970402660109)

GUDID

Device Identifier (DI) Information

Brand Name: Synthetic Polymer Teeth
Version or Model: KAIFENG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1*28*4
Company Name: Huge Dental Material Co., Ltd.

Primary DI Number: 06970402660109
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 420283541 *Terms of Use

Device Description: No description.

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Resin artificial teeth	Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

FDA Product Code

[?]

Product Code	Product Code Name
ELM	Denture, Plastic, Teeth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101029	000

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: 062950af-e887-4d26-b98e-3c010b8f3f95
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016