Contours™ Course Anatomy Trimers Starter Kit - Dental mandrel - CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Duns Number:626406016

Device Description: Dental mandrel

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More Product Details

Catalog Number

078918

Brand Name

Contours™ Course Anatomy Trimers Starter Kit

Version/Model Number

078918

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

3f51857c-9576-4335-99cb-43d2e6aad93b

Public Version Date

April 01, 2022

Public Version Number

1

DI Record Publish Date

March 24, 2022

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