Angled Abutment - ABUTMENT MINI ANGLED MORSE HEIGHT 3X17° - Sin Sistema de Implante Nacional S/A

Duns Number:904569092

Device Description: ABUTMENT MINI ANGLED MORSE HEIGHT 3X17°

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More Product Details

Catalog Number

MAAM 4803I

Brand Name

Angled Abutment

Version/Model Number

MAAM 4803I

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

K200992

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

b38917ff-2372-4cc1-82f5-b60c1f1a9ba3

Public Version Date

February 24, 2021

Public Version Number

1

DI Record Publish Date

February 16, 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