Catalog Number

1410504FG

Brand Name

Superdent® Eugenol U.S.P.

Version/Model Number

1410504FG

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 09, 2019

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

EMB

Product Code Name

ZINC OXIDE EUGENOL

Public Device Record Key

2e9e3258-efcf-408e-ace1-bea157c1cf61

Public Version Date

September 30, 2022

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-