AccessGUDID - DEVICE: YUCERA (06974242687029)

GUDID

Device Identifier (DI) Information

Brand Name: YUCERA
Version or Model: D3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HT 98×14mm
Company Name: Shenzhen Yurucheng Dental Materials Co., Ltd.

Primary DI Number: 06974242687029
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 402519411 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
16187	Dental appliance fabrication material, ceramic	A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PKJ	Crown And Bridge Material, Resin Based

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K214003	000
K214005	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: 6d573e70-acc2-47cd-81c7-d782b4242bc5
Public Version Date: August 07, 2023
Public Version Number: 1
DI Record Publish Date: July 28, 2023