Catalog Number

422886

Brand Name

MI Paste Plus™

Version/Model Number

422886

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

K070854,K070854

Product Code

EJR

Product Code Name

AGENT, POLISHING, ABRASIVE, ORAL CAVITY

Public Device Record Key

b198f910-3802-4804-921e-7fc2e47b08cd

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

February 10, 2017

Package DI Number

D6584228862

Quantity per Package

30

Contains DI Package

D6584228861

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-