Catalog Number

-

Brand Name

Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Version/Model Number

20×14×15（T0）

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

K160367,K160367

Product Code

EIH

Product Code Name

Powder, Porcelain

Public Device Record Key

a7899ba2-fbb8-4ebf-86c6-cf3dc98ffe8e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 26, 2017

Package DI Number

06970010340219

Quantity per Package

10

Contains DI Package

06970010340202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-