AccessGUDID - DEVICE: Zrcoop (06975409640079)

GUDID

Device Identifier (DI) Information

Brand Name: Zrcoop
Version or Model: Additive manufacturing of zirconia inlays
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hangzhou Thales Medtech Co., Ltd.

Primary DI Number: 06975409640079
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 841846639 *Terms of Use

Device Description: Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structure of prostheses for partially edentulous patients in need of prosthetic oral reconstruction to restore chewing function and aesthetics. The Additive Manufacturing Zirconia Customized Restoration is a premanufactured prosthetic component and is indicated for use as restorations (Crown,Bridge,Veneer,Inlay) that will be cemented to a natural or artificial tooth abutment.

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?
38588	Complete upper denture	A custom-made artificial replacement for all teeth in the upper jaw (maxilla) carried on a removable plate or frame which is supported by surrounding soft and hard tissues of the oral cavity. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELL	Teeth, Porcelain
EIH	Powder, Porcelain

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240586	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 76696780-f404-4cac-9689-946349f229cb
Public Version Date: January 13, 2025
Public Version Number: 1
DI Record Publish Date: January 03, 2025