HP DURA-GREEN - HP DURA-GREEN TC4 72 - SHOFU DENTAL CORPORATION

Duns Number:054618202

Device Description: HP DURA-GREEN TC4 72

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More Product Details

Catalog Number

HG42

Brand Name

HP DURA-GREEN

Version/Model Number

HG42

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

-

Prescription Use (Rx)

Yes

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

EHL

Product Code Name

POINT, ABRASIVE

Device Record Status

Public Device Record Key

ca9f0c17-260e-4517-a4b1-4be7d221bd8b

Public Version Date

February 11, 2021

Public Version Number

1

DI Record Publish Date

February 03, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHOFU DENTAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 691
2 A medical device with a moderate to high risk that requires special controls. 2950