Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

1002-4

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

0fe7cb66-7ba4-451a-8e22-7149b0b23021

Public Version Date

February 01, 2019

Public Version Number

1

DI Record Publish Date

January 01, 2019

Package DI Number

D838100248

Quantity per Package

5

Contains DI Package

D838100246

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case