Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

1002-4NC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K170261,K170261,K170261

Product Code

EFB

Product Code Name

Handpiece, Air-Powered, Dental

Public Device Record Key

40a7a47e-e160-4d62-bb0e-63fabf7b2dd2

Public Version Date

February 01, 2019

Public Version Number

1

DI Record Publish Date

January 01, 2019

Package DI Number

D83810024NC8

Quantity per Package

10

Contains DI Package

D83810024NC2

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case