AccessGUDID - DEVICE: Cast Crown Pure Tianium (06975031820030)

GUDID

Device Identifier (DI) Information

Brand Name: Cast Crown Pure Tianium
Version or Model: /
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Beijing Yingguan Dental Technology Co., Ltd.

Primary DI Number: 06975031820030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 560456141 *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):	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?
38591	Custom-made dental crown, metal	A device made totally of metal alloy material, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NSP	Restoration, Porcelain

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ozone
Ultraviolet Light

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: 60e130c6-16ca-4459-af8e-b7bb82a95416
Public Version Date: October 10, 2022
Public Version Number: 1
DI Record Publish Date: September 30, 2022