Catalog Number

D-46502S

Brand Name

TheraCem Ca

Version/Model Number

D-46502S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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

acec9ed9-b7ba-4c89-a452-43fc63fb9a35

Public Version Date

May 10, 2019

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

-