Catalog Number

-

Brand Name

StarDental Instrument Solutions

Version/Model Number

265996

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

Yes

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

K131578,K131578

Product Code

EKX

Product Code Name

Handpiece, Direct Drive, Ac-Powered

Public Device Record Key

56fcc938-2cba-4b5b-bde5-a7df45e47e4e

Public Version Date

March 03, 2020

Public Version Number

2

DI Record Publish Date

November 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-