Catalog Number

-

Brand Name

CanalPro

Version/Model Number

60013994

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

K082470

Product Code

KJJ

Product Code Name

Cleanser, Root Canal

Public Device Record Key

48d3fa27-b8c6-4b58-b32f-b1081860453a

Public Version Date

October 05, 2018

Public Version Number

4

DI Record Publish Date

June 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-