Catalog Number

H-931B1

Brand Name

Reveal HD Bulk

Version/Model Number

H-931B1

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

-

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

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

c76273b3-3eb9-43e6-9562-c5855abda688

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 07, 2022

Package DI Number

10810111542590

Quantity per Package

1

Contains DI Package

00810111542593

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Item No: H-931B1P