Catalog Number

101-5007

Brand Name

EsBond S2

Version/Model Number

101-5007

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

K092572,K092572

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

333b8065-49f6-4deb-a143-cc11c35b874a

Public Version Date

September 21, 2018

Public Version Number

1

DI Record Publish Date

August 21, 2018

Package DI Number

01904307170321

Quantity per Package

50

Contains DI Package

08809262959956

Package Discontinue Date

August 23, 2018

Package Status

Not in Commercial Distribution

Package Type

-