Catalog Number

MKZEM004

Brand Name

MKZ EM-Activator

Version/Model Number

MKZEM004

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EBI

Product Code Name

RESIN, DENTURE, RELINING, REPAIRING, REBASING

Public Device Record Key

d74b8dbe-ca9f-47fd-aaf3-74aa2af96231

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2016

Package DI Number

EBREMKZEM0049

Quantity per Package

1

Contains DI Package

EBREMKZEM0040

Package Discontinue Date

September 20, 2016

Package Status

Not in Commercial Distribution

Package Type

dummy