Catalog Number

42002

Brand Name

Athena Champion

Version/Model Number

42002

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

K790722,K790722

Product Code

EGS

Product Code Name

Handpiece, contra- and right-angle attachment, dental

Public Device Record Key

74e415c9-eb9c-4f0e-90ba-885c668930d8

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 16, 2022

Package DI Number

10302730001898

Quantity per Package

1

Contains DI Package

00302730001891

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box