Catalog Number

-

Brand Name

High-speed Turbine Handpieces for Single Use

Version/Model Number

TBY03-DZJQW

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

K172543,K172543

Product Code

EFB

Product Code Name

Handpiece, Air-Powered, Dental

Public Device Record Key

2f1583ac-5c51-4280-b575-ccdefbacac25

Public Version Date

March 16, 2020

Public Version Number

1

DI Record Publish Date

March 06, 2020

Package DI Number

06970278690408

Quantity per Package

10

Contains DI Package

06970278690286

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-