Catalog Number

-

Brand Name

CLEARFIL MAJESTY™ ES Flow

Version/Model Number

#3331-KA

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

K191980,K191980

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

9c3c0e89-46a5-48c0-8a98-697fb2234350

Public Version Date

August 10, 2021

Public Version Number

5

DI Record Publish Date

February 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-