Vericore Zirconia Blanks - Vericore Zirconia blanks are made from - WHIP-MIX CORPORATION

Duns Number:006385173

Device Description: Vericore Zirconia blanks are made from pre-sinteredzirconium dioxide intended to be used w Vericore Zirconia blanks are made from pre-sinteredzirconium dioxide intended to be used with CAD/CAMor manual milling machines. Vericore zirconia blanksare biocompatible and designed to fabricate zirconiastructures.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

74323

Brand Name

Vericore Zirconia Blanks

Version/Model Number

ZR PRO shaded A3

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 25, 2021

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

53b0ff8c-7aea-4764-8b83-2f764faf0289

Public Version Date

August 25, 2021

Public Version Number

3

DI Record Publish Date

March 04, 2018

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