EDENTA - Diamond HP - EDENTA ETABLISSEMENT

Duns Number:448002915

Device Description: Diamond HP

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More Product Details

Catalog Number

-

Brand Name

EDENTA

Version/Model Number

840.104.033

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)

-

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

DZP

Product Code Name

INSTRUMENT, DIAMOND, DENTAL

Device Record Status

Public Device Record Key

0fa587b0-cc4a-4ed6-a7a7-f751a18f620c

Public Version Date

February 11, 2022

Public Version Number

1

DI Record Publish Date

February 03, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EDENTA ETABLISSEMENT" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4741