Catalog Number

-

Brand Name

StarDental Instrument Solutions

Version/Model Number

202059

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 07, 2019

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

EKC

Product Code Name

Excavator, Dental, Operative

Public Device Record Key

fc08d16c-95b1-4147-b54e-2551cc8a625f

Public Version Date

April 30, 2019

Public Version Number

3

DI Record Publish Date

November 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-