Catalog Number

-

Brand Name

DuraMax

Version/Model Number

HP3057

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

K112623

Product Code

EFB

Product Code Name

Handpiece, Air-Powered, Dental

Public Device Record Key

11dff333-61ab-46b6-9f95-02665b61ac56

Public Version Date

August 04, 2020

Public Version Number

1

DI Record Publish Date

July 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-