Catalog Number

70-42621

Brand Name

Emoji Contours Soft Disposable Prophy Angles

Version/Model Number

7042621

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

-

Product Code

EHK

Product Code Name

Cup, Prophylaxis

Public Device Record Key

c0fa4181-81c7-4b55-90b0-aec391da6c45

Public Version Date

August 30, 2018

Public Version Number

1

DI Record Publish Date

July 30, 2018

Package DI Number

00723896011287

Quantity per Package

12

Contains DI Package

00723896011270

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case