Catalog Number

101-0501

Brand Name

EsBond

Version/Model Number

101-0501

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

K120767,K120767,K120767,K120767

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Public Device Record Key

200b3ebf-f00a-4479-a76b-270843aa3c04

Public Version Date

January 26, 2021

Public Version Number

7

DI Record Publish Date

February 20, 2017

Package DI Number

20210305180053

Quantity per Package

100

Contains DI Package

08809262955415

Package Discontinue Date

May 16, 2019

Package Status

Not in Commercial Distribution

Package Type

-