Vericore Zirconia Blanks - Whip Mix Vericore® Zirconia Blanks are made from - WHIP-MIX CORPORATION

Duns Number:006385173

Device Description: Whip Mix Vericore® Zirconia Blanks are made from Yttria stabilized zirconium powder. The 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.

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More Product Details

Catalog Number

74231

Brand Name

Vericore Zirconia Blanks

Version/Model Number

HTX Shaded Group WMX1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2020

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

EIH

Product Code Name

Powder, Porcelain

Device Record Status

Public Device Record Key

c4a548bc-d460-4429-9fa1-f6faa9b144cd

Public Version Date

August 25, 2021

Public Version Number

7

DI Record Publish Date

August 25, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WHIP-MIX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 63
2 A medical device with a moderate to high risk that requires special controls. 293
U Unclassified 1