Catalog Number

101-1013

Brand Name

Estemp Implant Cement

Version/Model Number

101-1013

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

K134021,K134021,K134021

Product Code

EMA

Product Code Name

Cement, Dental

Public Device Record Key

8cd01507-0423-4c01-995d-cc296fa8d3d6

Public Version Date

January 26, 2021

Public Version Number

4

DI Record Publish Date

August 23, 2018

Package DI Number

20200623170096

Quantity per Package

50

Contains DI Package

08809262954234

Package Discontinue Date

May 16, 2019

Package Status

Not in Commercial Distribution

Package Type

-