DEVICE: Vericore Zirconia Blanks (D040743471)
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Device Identifier (DI) Information
Vericore Zirconia Blanks
ZR PRO shaded BL
Not in Commercial Distribution
74347
WHIP-MIX CORPORATION
ZR PRO shaded BL
Not in Commercial Distribution
74347
WHIP-MIX CORPORATION
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
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 44727 | Dental porcelain/ceramic restoration kit |
A collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in the dental laboratory. This is a reusable device.
|
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 | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: 98mm X 20mm |
Device Record Status
04fd9f70-c229-417a-997c-aedb843603ce
August 25, 2021
3
March 06, 2018
August 25, 2021
3
March 06, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined