Catalog Number

60029848

Brand Name

K-Reamers

Version/Model Number

N015/040 L31

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EKP

Product Code Name

Reamer, Pulp Canal, Endodontic

Public Device Record Key

8a645c4d-0d0d-4383-8960-2b01723d3cde

Public Version Date

December 30, 2020

Public Version Number

1

DI Record Publish Date

December 22, 2020

Package DI Number

J015600298489

Quantity per Package

10

Contains DI Package

J015600298481

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box