Catalog Number

-

Brand Name

PROPHY PASTE

Version/Model Number

6070540575

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)

-

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

3dbf6cef-6e01-4944-b63b-e549eefd5291

Public Version Date

October 28, 2022

Public Version Number

1

DI Record Publish Date

October 20, 2022

Package DI Number

D89260705405752

Quantity per Package

4000

Contains DI Package

D89260705405751

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case