Catalog Number

-

Brand Name

High-speed Turbine Handpieces for Single Use

Version/Model Number

TBY03-BKJW

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

14e9f61a-461d-4bf0-804a-8c9c59bde66f

Public Version Date

January 11, 2019

Public Version Number

1

DI Record Publish Date

December 11, 2018

Package DI Number

06970278690170

Quantity per Package

10

Contains DI Package

06970278690125

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-