Catalog Number

-

Brand Name

CLEARFIL MAJESTY™ IC Bulk

Version/Model Number

#4232-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

-

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

K182430

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

612f10e5-4f76-4ee7-b292-0150a2bf43f7

Public Version Date

August 10, 2021

Public Version Number

2

DI Record Publish Date

June 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-