Catalog Number

5702457

Brand Name

Henry Schein

Version/Model Number

5702457

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Public Device Record Key

805566a4-8c61-4a7e-8361-c3941decdac9

Public Version Date

March 22, 2021

Public Version Number

1

DI Record Publish Date

March 12, 2021

Package DI Number

20304040142619

Quantity per Package

100

Contains DI Package

10304040142612

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case