Catalog Number

H-9332A2

Brand Name

Reveal HD Bulk

Version/Model Number

H-9332A2

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171147,K171147,K171147

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

c3b9cf6c-d14a-4906-a098-e91c154c7067

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

September 30, 2022

Package DI Number

30810111542617

Quantity per Package

1

Contains DI Package

20810111542610

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-