Catalog Number

-

Brand Name

StarDental Instrument Solutions

Version/Model Number

200334

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 22, 2022

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

-

Product Code

DZP

Product Code Name

Instrument, Diamond, Dental

Public Device Record Key

694a4cba-86f8-43fc-91f4-6dc192fff169

Public Version Date

July 25, 2022

Public Version Number

4

DI Record Publish Date

November 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-