Catalog Number

-

Brand Name

StarDental Instrument Solutions

Version/Model Number

265676

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

K944271

Product Code

EIA

Product Code Name

Unit, Operative Dental

Public Device Record Key

68f6205b-836a-4a9b-bfb1-6973449e6911

Public Version Date

December 06, 2018

Public Version Number

1

DI Record Publish Date

November 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-