N/A - Titanium Abutment Base for Int. Hex, Non-Engaging - SOUTHERN IMPLANTS (PTY) LTD

Duns Number:636239584

Device Description: Titanium Abutment Base for Int. Hex, Non-Engaging

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

TIB-NM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K193084

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

85e90c75-ad43-4b62-a024-d9b86e2f50d8

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

March 31, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SOUTHERN IMPLANTS (PTY) LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1050
2 A medical device with a moderate to high risk that requires special controls. 1479