Catalog Number

D-46501

Brand Name

TheraCem Ca

Version/Model Number

D-46501

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 10, 2022

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

K161256

Product Code

EMA

Product Code Name

Cement, Dental

Public Device Record Key

3c2f72ed-c07f-4b6a-9f37-1d5b5476b63d

Public Version Date

October 11, 2022

Public Version Number

4

DI Record Publish Date

March 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-