TPC - Digital dental amalgamator used for mixing dental - TPC ADVANCE TECHNOLOGY, INC.

Duns Number:968884275

Device Description: Digital dental amalgamator used for mixing dental amalgam.

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More Product Details

Catalog Number

D650

Brand Name

TPC

Version/Model Number

D650N

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

a2e008cc-2459-404e-a2b7-9b2ee96fe160

Public Version Date

September 24, 2018

Public Version Number

1

DI Record Publish Date

August 22, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TPC ADVANCE TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 15