Catalog Number

05331100R

Brand Name

K-REAMERS

Version/Model Number

05331100R

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

Yes

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

EKP

Product Code Name

REAMER, PULP CANAL, ENDODONTIC

Public Device Record Key

57e04f07-d58b-43ca-b1af-5bef9da627d6

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-