GUDID 06009544002611

Scanning Abutment, Non-Engaging, for Ø5.0 Tri-Nex

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed
Primary Device ID06009544002611
NIH Device Record Key77b7ef2b-f68d-4426-92aa-9ba465d04a40
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCIA-NL-50
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106009544002611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

[06009544002611]

Moist Heat or Steam Sterilization


[06009544002611]

Moist Heat or Steam Sterilization


[06009544002611]

Moist Heat or Steam Sterilization


[06009544002611]

Moist Heat or Steam Sterilization


[06009544002611]

Moist Heat or Steam Sterilization


[06009544002611]

Moist Heat or Steam Sterilization


[06009544002611]

Moist Heat or Steam Sterilization


[06009544002611]

Moist Heat or Steam Sterilization


[06009544002611]

Moist Heat or Steam Sterilization


[06009544002611]

Moist Heat or Steam Sterilization


[06009544002611]

Moist Heat or Steam Sterilization


[06009544002611]

Moist Heat or Steam Sterilization


[06009544002611]

Moist Heat or Steam Sterilization


[06009544002611]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-01-09

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

06009544000105 - NA2025-07-17 Abutment Healing Int Hex PM 6.5x6
06009544050438 - N/A2025-07-17 Abutment Healing SP1 ø3.8x2.5mm
06009544050445 - N/A2025-07-17 Abutment Healing SP1 ø3.8x3.5mm
06009544050452 - N/A2025-07-17 Abutment Healing SP1 ø3.8x4.5mm
06009544050469 - N/A2025-07-17 Abutment Healing SP1 ø3.8x5.5mm
06009544050476 - N/A2025-07-17 Abutment Healing SP1 ø3.8x6.5mm
06009544050483 - N/A2025-07-17 Abutment Healing SP1 ø4.5x6.5mm
06009544050490 - N/A2025-07-17 Abutment Healing SP1 ø5.0x6.5mm

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