Catalog Number

-

Brand Name

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Version/Model Number

SHT

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

328cb80e-445b-4bf0-9a2b-c49a911f6915

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

September 30, 2022

Package DI Number

16975018580121

Quantity per Package

40

Contains DI Package

06975018580124

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-