Catalog Number

KS4-F

Brand Name

NTI

Version/Model Number

KS4-024F-FG

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

DZP

Product Code Name

INSTRUMENT, DIAMOND, DENTAL

Public Device Record Key

55126127-3e27-45c9-885b-d0066ec74d93

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

January 01, 2022

Package DI Number

E310KS4024FFG2

Quantity per Package

5

Contains DI Package

E310KS4024FFG1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-