Catalog Number

-

Brand Name

E-ON

Version/Model Number

5053-372

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

-

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

13b197e5-89b7-47a7-8af0-311c94a619de

Public Version Date

August 21, 2019

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

D74450533721

Quantity per Package

1

Contains DI Package

D74450533720

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box