Catalog Number

60019563

Brand Name

DuoCem

Version/Model Number

60019563

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 01, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160800

Product Code

EMA

Product Code Name

Cement, Dental

Public Device Record Key

371fb0b3-80d8-41db-a879-1133772b2ec7

Public Version Date

November 22, 2021

Public Version Number

4

DI Record Publish Date

January 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-