Catalog Number

266071

Brand Name

StarDental

Version/Model Number

266071

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

K192412

Product Code

EFB

Product Code Name

Handpiece, Air-Powered, Dental

Public Device Record Key

c8fab3c9-d905-4ce2-99fd-a6b1a98b7864

Public Version Date

June 22, 2022

Public Version Number

2

DI Record Publish Date

February 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-