Mini Abutment - ABUTMENT MINI INT HEX Ø4,5 X 4MM - Sin Sistema de Implante Nacional S/A

Duns Number:904569092

Device Description: ABUTMENT MINI INT HEX Ø4,5 X 4MM

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More Product Details

Catalog Number

MAS 4504

Brand Name

Mini Abutment

Version/Model Number

MAS 4504

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

K170398

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

fefc23bf-2d56-4936-9078-35b3c7362629

Public Version Date

March 09, 2021

Public Version Number

1

DI Record Publish Date

March 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIN SISTEMA DE IMPLANTE NACIONAL S/A" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1337