Catalog Number

101-1012

Brand Name

Estemp NE Temporary Cement

Version/Model Number

101-1012

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

61d36bb5-3124-4971-8c43-40db5ef2bcb7

Public Version Date

August 11, 2022

Public Version Number

4

DI Record Publish Date

August 23, 2018

Package DI Number

00202102110667

Quantity per Package

54

Contains DI Package

08809262954227

Package Discontinue Date

January 25, 2021

Package Status

Not in Commercial Distribution

Package Type

-