Catalog Number

9533408

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9533408

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

Yes

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

-

Product Code

EKK

Product Code Name

SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC

Public Device Record Key

f4b1bdae-40b6-45ea-9142-22f6b82b959f

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 12, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-