Catalog Number

10-1010

Brand Name

KöR

Version/Model Number

KöR Desensitizer-10ml

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K953405

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Public Device Record Key

5626a3b9-c33e-4e0c-b95a-397e69a27490

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

January 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-