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.
Catalog Number
74307
Brand Name
Vericore Zirconia Blank
Version/Model Number
ZR PRO
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 25, 2021
Issuing Agency
In HIBCC
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
EIH
Product Code Name
Powder, Porcelain
Public Device Record Key
ee7775f2-0b9a-44cc-94d5-578ee0343599
Public Version Date
August 25, 2021
Public Version Number
3
DI Record Publish Date
March 04, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |