Catalog Number

-

Brand Name

PANAVIA SA Cement Universal

Version/Model Number

#4221-KA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Yes

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

K183537,K183537

Product Code

EMA

Product Code Name

Cement, Dental

Public Device Record Key

0e345f71-0de6-4aa5-868f-6ea05360ed3f

Public Version Date

August 10, 2021

Public Version Number

2

DI Record Publish Date

June 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-