PowerMix™ Automatic Impression Material Dispenser - Two-component dental material applicator, electric - CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Duns Number:626406016

Device Description: Two-component dental material applicator, electric

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More Product Details

Catalog Number

031121

Brand Name

PowerMix™ Automatic Impression Material Dispenser

Version/Model Number

031121

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

EFD

Product Code Name

AMALGAMATOR, DENTAL, AC-POWERED

Device Record Status

Public Device Record Key

cf94ce7a-24a6-4a34-bc65-7476712bc0b2

Public Version Date

November 01, 2022

Public Version Number

5

DI Record Publish Date

September 10, 2018

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