Biodenta - Ball Abutment / B2 / GH 4.0 / BL & TP - Biodenta Swiss AG

Duns Number:484609081

Device Description: Ball Abutment / B2 / GH 4.0 / BL & TP

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More Product Details

Catalog Number

BL-B018GH4B

Brand Name

Biodenta

Version/Model Number

BL-B018GH4B

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

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

K111003

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

2941fc8f-c2f2-4320-aa89-cbe6f5db8f21

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

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