Catalog Number

199-3065

Brand Name

SCOTT'S HANDHELD AUTOMIX CORE 2/pk BLUE

Version/Model Number

199-3065

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K022675

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

20091673-6efa-4d93-bce2-dd77e7577c08

Public Version Date

August 26, 2020

Public Version Number

4

DI Record Publish Date

June 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-