AccessGUDID - DEVICE: Vericore Zirconia Blanks (D040728131)

GUDID

Device Identifier (DI) Information

Brand Name: Vericore Zirconia Blanks
Version or Model: HT Shaded A1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 72813
Company Name: WHIP-MIX CORPORATION

Primary DI Number: D040728131
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: Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The powder is pressed into either a circular disc or rectangular block. The product is then sintered after pressing and this process is called pre-sintering. The customer then mills the doctor prescribed restoration/framework from the blank and then performs the final sintering. This may include available staining and glazing, but the stain and glaze products are not supplied by Whip Mix. They are available in a variety of sizes and shades.

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):	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: 20mm X 98mm

Device Record Status

Public Device Record Key: dfe28b33-07c4-49b9-889f-547d8328d3e4
Public Version Date: August 26, 2021
Public Version Number: 5
DI Record Publish Date: August 22, 2016