GUDID 06009544013730

Titanium Cylinder for IT Ø6.5 Interface Passive Abutment, Non-Engaging

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed
Primary Device ID06009544013730
NIH Device Record Key8813f6a7-b44f-4813-9c4f-7ac522766890
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberITS6-PA-NETC
Company DUNS636239584
Company NameSOUTHERN IMPLANTS (PTY) LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106009544013730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

[06009544013730]

Moist Heat or Steam Sterilization


[06009544013730]

Moist Heat or Steam Sterilization


[06009544013730]

Moist Heat or Steam Sterilization


[06009544013730]

Moist Heat or Steam Sterilization


[06009544013730]

Moist Heat or Steam Sterilization


[06009544013730]

Moist Heat or Steam Sterilization


[06009544013730]

Moist Heat or Steam Sterilization


[06009544013730]

Moist Heat or Steam Sterilization


[06009544013730]

Moist Heat or Steam Sterilization


[06009544013730]

Moist Heat or Steam Sterilization


[06009544013730]

Moist Heat or Steam Sterilization


[06009544013730]

Moist Heat or Steam Sterilization


[06009544013730]

Moist Heat or Steam Sterilization


[06009544013730]

Moist Heat or Steam Sterilization


[06009544013730]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-01-23

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06009544047872 - N/A2025-11-25 Titanium Blank for Ø5.0 Tri-Nex, Ø11.5mm
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