Biodenta - Universal Analog Compatible with Nobel Branemark - Biodenta Swiss AG

Duns Number:484609081

Device Description: Universal Analog Compatible with Nobel Branemark NP/RP - Active NP/RP - Replace NP/RP/WP M Universal Analog Compatible with Nobel Branemark NP/RP - Active NP/RP - Replace NP/RP/WP Multi-Unit Abutment

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More Product Details

Catalog Number

CAD-UANMUNRW

Brand Name

Biodenta

Version/Model Number

CAD-UANMUNRW

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)

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

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

9820d0c9-c31f-47e2-ad83-a11b1f842e78

Public Version Date

June 15, 2020

Public Version Number

1

DI Record Publish Date

June 05, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIODENTA SWISS AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 43
2 A medical device with a moderate to high risk that requires special controls. 193