Catalog Number

101-5006

Brand Name

Esbond S1

Version/Model Number

101-5006

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,K092572

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

c87beec7-fe17-4ead-b3e4-ab1ea72b3c7f

Public Version Date

March 13, 2019

Public Version Number

2

DI Record Publish Date

August 21, 2018

Package DI Number

20200630518041

Quantity per Package

50

Contains DI Package

08809262959949

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-