Catalog Number

-

Brand Name

Impact Air 45®

Version/Model Number

402

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

K952927,K972375,K972376

Product Code

EFB

Product Code Name

Handpiece, Air-Powered, Dental

Public Device Record Key

c8139fb8-ce23-49d7-ade1-a32522a5aea1

Public Version Date

December 17, 2021

Public Version Number

2

DI Record Publish Date

April 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-