Catalog Number

1198

Brand Name

IP-TempCement

Version/Model Number

1198

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2019

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

K111685

Product Code

EMA

Product Code Name

Cement, Dental

Public Device Record Key

ace516be-01b6-4b08-b8ca-66fe34b099d1

Public Version Date

December 02, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-