AccessGUDID - DEVICE: Vericore ZR Pro (D040743571)

GUDID

Device Identifier (DI) Information

Brand Name: Vericore ZR Pro
Version or Model: 74357
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 74357
Company Name: WHIP-MIX CORPORATION

Primary DI Number: D040743571
Issuing Agency: HIBCC
Commercial Distribution End Date: February 25, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 006385173 *Terms of Use

Device Description: Vericore Zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with CAD/CAM or manual milling machines. Vericore zirconia blanks are biocompatible and designed to fabricate zirconia structures.

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:	No
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38594	Custom-made dental crown, ceramic	A device made totally of ceramic 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
EIH	Powder, Porcelain

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Device Size Text, specify: 98mm X 12mm

Device Record Status

Public Device Record Key: 10de1525-c432-4111-a2ed-28e78d0ab157
Public Version Date: August 25, 2021
Public Version Number: 3
DI Record Publish Date: February 18, 2020