Catalog Number

801607

Brand Name

NUPRO® Extra Care™ Prophy Paste with fluoride & NovaMin®

Version/Model Number

801607

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

-

Product Code

EJR

Product Code Name

AGENT, POLISHING, ABRASIVE, ORAL CAVITY

Public Device Record Key

09169d5b-e713-49d1-bc93-2e90ddbfdbfb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

D0038016072

Quantity per Package

4

Contains DI Package

D0038016071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case