Catalog Number

ZEN-MTA-UNI

Brand Name

MTA Capsules

Version/Model Number

ZEN-MTA-UNI

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KIF

Product Code Name

Resin, Root Canal Filling

Public Device Record Key

df11e9d7-b27a-4f99-a780-520ab05ee712

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 15, 2016

Package DI Number

27540208000398

Quantity per Package

1

Contains DI Package

17540208000391

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton