N/A

GUDID 06009544044260

SI-Base Abutment, Engaging, for Ø3.5/Ø4.0 DC, Ø4.8

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed
Primary Device ID06009544044260
NIH Device Record Key6934da3c-08c9-4c2b-ac6e-2528a2cd5830
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberSIB-DC4-48C3
Company DUNS636239584
Company NameSOUTHERN IMPLANTS (PTY) LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS106009544044260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06009544044260]

Moist Heat or Steam Sterilization


[06009544044260]

Moist Heat or Steam Sterilization


[06009544044260]

Moist Heat or Steam Sterilization


[06009544044260]

Moist Heat or Steam Sterilization


[06009544044260]

Moist Heat or Steam Sterilization


[06009544044260]

Moist Heat or Steam Sterilization


[06009544044260]

Moist Heat or Steam Sterilization


[06009544044260]

Moist Heat or Steam Sterilization


[06009544044260]

Moist Heat or Steam Sterilization


[06009544044260]

Moist Heat or Steam Sterilization


[06009544044260]

Moist Heat or Steam Sterilization


[06009544044260]

Moist Heat or Steam Sterilization


[06009544044260]

Moist Heat or Steam Sterilization


[06009544044260]

Moist Heat or Steam Sterilization


[06009544044260]

Moist Heat or Steam Sterilization


[06009544044260]

Moist Heat or Steam Sterilization


[06009544044260]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-11
Device Publish Date2024-01-03

On-Brand Devices [N/A]

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06009544036821Instr Direction Indicator IV
06009544036814Instr Direction Indicator 12° IV
06009544035411Driver Drill Guide Rohner Tech
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06009544029847Plastic Sleeve for Int. Hex Passive Abutment, Engaging
06009544029830Titanium Cylinder for Int. Hex Passive Abutment, Engaging
06009544029823Titanium Cylinder for Int. Hex Passive Abutment, Non-Engaging
06009544028499Titanium Cylinder for Ø5.0 DC Passive Abutment, Non-Engaging
06009544028482Titanium Cylinder for Ø3.5 / Ø4.0 DC Passive Abutment, Non-Engaging
06009544028475Titanium Cylinder for Ø3.0 DC Passive Abutment, Non-Engaging
06009544028468Plastic Sleeve for Ø5.0 DC Passive Abutment, Non-Engaging
06009544028451Plastic Sleeve for Ø3.5 / Ø4.0 DC Passive Abutment, Non-Engaging
06009544028444Plastic Sleeve for Ø3.0 DC Passive Abutment, Non-Engaging
06009544027997Passive Abutment for Int. Hex, Engaging
06009544027980Passive Abutment for Int. Hex, Non-Engaging
06009544027959Titanium Abutment for Int. Hex, Non-Engaging, 3mm Cuff
06009544027942Titanium Abutment for Int. Hex, Non-Engaging, 1mm Cuff
06009544027935Titanium Abutment for Int. Hex, Engaging, 3mm Cuff
06009544027928Titanium Abutment for Int. Hex, Engaging, 1mm Cuff
06009544022107Titanium Abutment, Smooth, for Ø4.8 Compact Conical
06009544021643Vertical Titanium Abutment, Non-Engaging, for Ø5.0 Ex Hex, 1mm Cuff
06009544021636Vertical Titanium Abutment, Engaging, for Ø5.0 Ex Hex, 1mm Cuff
06009544020509Passive Abutment, Non-Engaging, for Max9 Ex Hex
06009544020493Passive Abutment, Engaging, for Max9 Ex Hex
06009544019770Vertical Passive Abutment, Engaging, for Ø3.25 Ex Hex
06009544019756Titanium Cylinder for Ø3.25 Ex Hex Passive Abutment, Non-Engaging
06009544019749Passive Abutment, Non-Engaging, for Ø3.25 Ex Hex
06009544019725Titanium Cylinder for Ø3.25 Ex Hex Passive Abutment, Engaging
06009544019701Passive Abutment, Engaging, for Ø3.25 Ex Hex
06009544019657Titanium Cylinder for Ø6.0 Ex Hex Passive Abutment, Non-Engaging
06009544019640Passive Abutment, Non-Engaging, for Ø6.0 Ex Hex
06009544019633Plastic Sleeve for Ø6.0 Ex Hex Passive Abutment, Non-Engaging
06009544019626Titanium Cylinder for Ø6.0 Ex Hex Passive Abutment, Engaging
06009544019619Plastic Sleeve for Ø6.0 Ex Hex Passive Abutment, Engaging
06009544019602Passive Abutment, Engaging, for Ø6.0 Ex Hex
06009544019572Titanium Cylinder for Ø5.0 Ex Hex Passive Abutment, Non-Engaging
06009544019565Passive Abutment, Non-Engaging, for Ø5.0 Ex Hex
06009544019558Plastic Sleeve for Ø5.0 Ex Hex Passive Abutment, Non-Engaging
06009544019541Titanium Cylinder for Ø5.0 Ex Hex Passive Abutment, Engaging
06009544019534Plastic Sleeve for Ø5.0 Ex Hex Passive Abutment, Engaging
06009544019527Passive Abutment, Engaging, for Ø5.0 Ex Hex
06009544019497Titanium Cylinder for Ø4.0 Ex Hex Passive Abutment, Non-Engaging
06009544019473Plastic Sleeve for Ø4.0 Ex Hex Passive Abutment, Non-Engaging
06009544019466Titanium Cylinder for Ø4.0 Ex Hex Passive Abutment, Engaging
06009544018391Titanium Cylinder for Int. Hex Passive Abutment, Non-Engaging
06009544018384Plastic Sleeve for Int. Hex Passive Abutment, Non-Engaging
06009544018377Passive Abutment for Int. Hex, Non-Engaging
06009544018360Titanium Cylinder for Ø6.0 Tri-Nex Passive Abutment, Non-Engaging
06009544018353Plastic Sleeve for Ø6.0 Tri-Nex Passive Abutment, Non-Engaging

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