RED-COTE - This is a caries detection device. It is a plaque - SUNSTAR AMERICAS, INC.

Duns Number:025066358

Device Description: This is a caries detection device. It is a plaque disclosing tablet that helps detect dent This is a caries detection device. It is a plaque disclosing tablet that helps detect dental plaque on teeth. The red color reveals areas overlooked when brushing and flossing

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More Product Details

Catalog Number

-

Brand Name

RED-COTE

Version/Model Number

800 and 824

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

NYH

Product Code Name

Plaque Disclosing Kit

Device Record Status

Public Device Record Key

d8efea4c-c5f6-45ce-8218-1a390094d1af

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUNSTAR AMERICAS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 12