FRIADENT® - CERCON® Abutment dentin, angled D3.8/GH2/A15 - Dentsply Implants Manufacturing GmbH

Duns Number:344038836

Device Description: CERCON® Abutment dentin, angled D3.8/GH2/A15

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More Product Details

Catalog Number

47-2242

Brand Name

FRIADENT®

Version/Model Number

32472242

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 06, 2020

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)

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

NHA

Product Code Name

ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Device Record Status

Public Device Record Key

03fcea03-520e-40b8-a8cd-704e0e3764a4

Public Version Date

December 07, 2020

Public Version Number

5

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTSPLY IMPLANTS MANUFACTURING GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1379
2 A medical device with a moderate to high risk that requires special controls. 2266