Catalog Number

-

Brand Name

AIR-FLOW

Version/Model Number

DT-476A/US

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

Yes

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

K171174,K171174

Product Code

EFB

Product Code Name

Handpiece, Air-Powered, Dental

Public Device Record Key

f75907a4-4ff7-4a5c-bce4-48a120b082da

Public Version Date

November 10, 2020

Public Version Number

1

DI Record Publish Date

November 02, 2020

Package DI Number

07613353204563

Quantity per Package

4

Contains DI Package

07613353198312

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-