Catalog Number

-

Brand Name

E-ON

Version/Model Number

5053-363

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

2023c377-9bbe-4de0-b013-3aec5be22b9c

Public Version Date

August 21, 2019

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

D74450533631

Quantity per Package

1

Contains DI Package

D74450533630

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box