Catalog Number

7159810 coa

Brand Name

PractiPro Mint TCP Prophy Paste Coarse

Version/Model Number

7159810 coa

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K062166,K062166

Product Code

EJR

Product Code Name

Agent, Polishing, Abrasive, Oral Cavity

Public Device Record Key

fce73b8a-72e3-47a6-a08d-4c6bcf207916

Public Version Date

June 06, 2022

Public Version Number

1

DI Record Publish Date

May 27, 2022

Package DI Number

00723896021279

Quantity per Package

5

Contains DI Package

00723896021262

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case