Catalog Number

101-1011

Brand Name

Estemp Eugenol Temporary Cement

Version/Model Number

101-1011

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

K100290,K100290,K100290,K100290

Product Code

EMA

Product Code Name

Cement, Dental

Public Device Record Key

4b06e4be-583e-4631-884a-575e542d9e94

Public Version Date

July 26, 2022

Public Version Number

4

DI Record Publish Date

August 23, 2018

Package DI Number

20200305180030

Quantity per Package

10

Contains DI Package

08809262954210

Package Discontinue Date

May 16, 2019

Package Status

Not in Commercial Distribution

Package Type

-