GUDID 06009544011064

Ext. Hex Cylindrical Implant, Ultra-Short, Ø3.75 x 6mm

SOUTHERN IMPLANTS (PTY) LTD

Screw endosteal dental implant, two-piece
Primary Device ID06009544011064
NIH Device Record Key90519d6f-f61a-418f-a9a7-cd687dc118c8
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberIE6
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
GS106009544011064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FZEProsthesis, Nose, Internal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-15
Device Publish Date2019-01-15

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

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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

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