Catalog Number

-

Brand Name

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Version/Model Number

3D-pro-ML

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

-

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

K212259,K212259

Product Code

EIH

Product Code Name

Powder, Porcelain

Public Device Record Key

caeef783-8b91-4c2b-bd62-7074cad2413c

Public Version Date

January 17, 2022

Public Version Number

1

DI Record Publish Date

January 08, 2022

Package DI Number

16975018580084

Quantity per Package

40

Contains DI Package

06975018580087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-