Catalog Number

801534

Brand Name

NUPRO® Sensodyne® Prophylaxis Paste with Fluoride and NovaMin®

Version/Model Number

801534

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

-

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

-

Product Code

EJR

Product Code Name

AGENT, POLISHING, ABRASIVE, ORAL CAVITY

Public Device Record Key

6be0d6a2-7c95-4b58-8666-9d140889a532

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

D0038015342

Quantity per Package

4

Contains DI Package

D0038015341

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case