Catalog Number

56400

Brand Name

Young

Version/Model Number

56400

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K974670,K974670

Product Code

EFB

Product Code Name

Handpiece, air-powered, dental

Public Device Record Key

e33aefe9-df47-4440-a0ad-951d5517362d

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 16, 2022

Package DI Number

10302730001904

Quantity per Package

1

Contains DI Package

00302730001907

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box