Catalog Number

-

Brand Name

EzTemp C&B A1

Version/Model Number

101-5001

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

-

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Public Device Record Key

3826b1aa-89bc-472d-91a4-c22411009ccc

Public Version Date

March 20, 2019

Public Version Number

1

DI Record Publish Date

March 12, 2019

Package DI Number

21033119030111

Quantity per Package

50

Contains DI Package

08809262959918

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-