Catalog Number

-

Brand Name

Upcera Dental Zirconia Pre-Shaded Blank

Version/Model Number

S-0M3 D98-25

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

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

b1709e6a-f1f1-42ad-a6a2-616539ce1101

Public Version Date

April 18, 2022

Public Version Number

1

DI Record Publish Date

April 09, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-