AccessGUDID - DEVICE: XTCERA (06970544020236)

GUDID

Device Identifier (DI) Information

Brand Name: XTCERA
Version or Model: XW98*22
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Xiangtong Photoelectricity Technology Co., Ltd

Primary DI Number: 06970544020236
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 547044326 *Terms of Use

Device Description: SHT

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

GMDN Preferred Term Name	GMDN Definition
Dental porcelain/ceramic restoration kit	A collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in the dental laboratory. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
EIH	Powder, Porcelain

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153767	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: 0a551248-7c31-48da-b2b5-d7be8ab7db52
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016