Groovy Diamond® Polishing Brushes Tri-Pack - Dental polishing brush - CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Duns Number:626406016

Device Description: Dental polishing brush

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More Product Details

Catalog Number

650124

Brand Name

Groovy Diamond® Polishing Brushes Tri-Pack

Version/Model Number

650124

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

EJR

Product Code Name

AGENT, POLISHING, ABRASIVE, ORAL CAVITY

Device Record Status

Public Device Record Key

23ed5a8f-2fb5-4c77-b2b8-5bf5f81a05b3

Public Version Date

November 05, 2020

Public Version Number

1

DI Record Publish Date

October 28, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLINICIAN'S CHOICE DENTAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1461
2 A medical device with a moderate to high risk that requires special controls. 234
U Unclassified 6