Catalog Number

-

Brand Name

C-Root

Version/Model Number

2g

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K212983,K212983

Product Code

KIF

Product Code Name

Resin, Root Canal Filling

Public Device Record Key

0b0a8a28-6a75-4898-9cec-2cad17eaaffb

Public Version Date

March 09, 2022

Public Version Number

1

DI Record Publish Date

March 01, 2022

Package DI Number

16972902583398

Quantity per Package

60

Contains DI Package

06972902583391

Package Discontinue Date

March 01, 2022

Package Status

Not in Commercial Distribution

Package Type

box