Catalog Number

ZEN-MTA-FRMFSTSET

Brand Name

MTA Firm-Fast Set

Version/Model Number

ZEN-MTA-FRMFSTSET

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

401ddd53-1062-4028-ba2d-d63e0a909978

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 23, 2017

Package DI Number

27540208000411

Quantity per Package

1

Contains DI Package

17540208000414

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton