Catalog Number

070906

Brand Name

D-Fine™ Diamond Polishers for Hybrid Composites Trial Kit #06

Version/Model Number

070906

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 16, 2021

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

EJR

Product Code Name

AGENT, POLISHING, ABRASIVE, ORAL CAVITY

Public Device Record Key

c5448d45-1cd8-49d9-a5df-a728caf6023a

Public Version Date

November 01, 2022

Public Version Number

2

DI Record Publish Date

October 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-