Catalog Number

-

Brand Name

Burkhart Flowable Composite B3 Syringe 1ML/5-20G Tips

Version/Model Number

72720398

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

-

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

3d3d4db2-c2a2-4bff-a6cf-f0855e17897f

Public Version Date

November 08, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

00854212006301

Quantity per Package

3

Contains DI Package

00854212006295

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-