N/A

GUDID 06009544038436

INVERTA®, Ø3.0 ExHex 12° CO-AXIS®, Ø3.75 x 15mm

SOUTHERN IMPLANTS (PTY) LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 06009544038436
• NIH Device Record Key: 97569cd6-fc0a-43b8-a57e-b770364aa048
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: IV-EX3012D-3715
• Company DUNS: 636239584
• Company Name: SOUTHERN IMPLANTS (PTY) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06009544038436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173706

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-21
• Device Publish Date: 2022-10-13

On-Brand Devices [N/A]

• 06009544036845: Instrument Zyg Z Depth Gauge
• 06009544036821: Instr Direction Indicator IV
• 06009544036814: Instr Direction Indicator 12° IV
• 06009544035411: Driver Drill Guide Rohner Tech
• 06009544031918: Passive Abutment for Int. Hex, Engaging, Ø4.5 Platform Match
• 06009544029847: Plastic Sleeve for Int. Hex Passive Abutment, Engaging
• 06009544029830: Titanium Cylinder for Int. Hex Passive Abutment, Engaging
• 06009544029823: Titanium Cylinder for Int. Hex Passive Abutment, Non-Engaging
• 06009544028499: Titanium Cylinder for Ø5.0 DC Passive Abutment, Non-Engaging
• 06009544028482: Titanium Cylinder for Ø3.5 / Ø4.0 DC Passive Abutment, Non-Engaging
• 06009544028475: Titanium Cylinder for Ø3.0 DC Passive Abutment, Non-Engaging
• 06009544028468: Plastic Sleeve for Ø5.0 DC Passive Abutment, Non-Engaging
• 06009544028451: Plastic Sleeve for Ø3.5 / Ø4.0 DC Passive Abutment, Non-Engaging
• 06009544028444: Plastic Sleeve for Ø3.0 DC Passive Abutment, Non-Engaging
• 06009544027997: Passive Abutment for Int. Hex, Engaging
• 06009544027980: Passive Abutment for Int. Hex, Non-Engaging
• 06009544027959: Titanium Abutment for Int. Hex, Non-Engaging, 3mm Cuff
• 06009544027942: Titanium Abutment for Int. Hex, Non-Engaging, 1mm Cuff
• 06009544027935: Titanium Abutment for Int. Hex, Engaging, 3mm Cuff
• 06009544027928: Titanium Abutment for Int. Hex, Engaging, 1mm Cuff
• 06009544022107: Titanium Abutment, Smooth, for Ø4.8 Compact Conical
• 06009544021643: Vertical Titanium Abutment, Non-Engaging, for Ø5.0 Ex Hex, 1mm Cuff
• 06009544021636: Vertical Titanium Abutment, Engaging, for Ø5.0 Ex Hex, 1mm Cuff
• 06009544020509: Passive Abutment, Non-Engaging, for Max9 Ex Hex
• 06009544020493: Passive Abutment, Engaging, for Max9 Ex Hex
• 06009544019770: Vertical Passive Abutment, Engaging, for Ø3.25 Ex Hex
• 06009544019756: Titanium Cylinder for Ø3.25 Ex Hex Passive Abutment, Non-Engaging
• 06009544019749: Passive Abutment, Non-Engaging, for Ø3.25 Ex Hex
• 06009544019725: Titanium Cylinder for Ø3.25 Ex Hex Passive Abutment, Engaging
• 06009544019701: Passive Abutment, Engaging, for Ø3.25 Ex Hex
• 06009544019657: Titanium Cylinder for Ø6.0 Ex Hex Passive Abutment, Non-Engaging
• 06009544019640: Passive Abutment, Non-Engaging, for Ø6.0 Ex Hex
• 06009544019633: Plastic Sleeve for Ø6.0 Ex Hex Passive Abutment, Non-Engaging
• 06009544019626: Titanium Cylinder for Ø6.0 Ex Hex Passive Abutment, Engaging
• 06009544019619: Plastic Sleeve for Ø6.0 Ex Hex Passive Abutment, Engaging
• 06009544019602: Passive Abutment, Engaging, for Ø6.0 Ex Hex
• 06009544019572: Titanium Cylinder for Ø5.0 Ex Hex Passive Abutment, Non-Engaging
• 06009544019565: Passive Abutment, Non-Engaging, for Ø5.0 Ex Hex
• 06009544019558: Plastic Sleeve for Ø5.0 Ex Hex Passive Abutment, Non-Engaging
• 06009544019541: Titanium Cylinder for Ø5.0 Ex Hex Passive Abutment, Engaging
• 06009544019534: Plastic Sleeve for Ø5.0 Ex Hex Passive Abutment, Engaging
• 06009544019527: Passive Abutment, Engaging, for Ø5.0 Ex Hex
• 06009544019497: Titanium Cylinder for Ø4.0 Ex Hex Passive Abutment, Non-Engaging
• 06009544019473: Plastic Sleeve for Ø4.0 Ex Hex Passive Abutment, Non-Engaging
• 06009544019466: Titanium Cylinder for Ø4.0 Ex Hex Passive Abutment, Engaging
• 06009544018391: Titanium Cylinder for Int. Hex Passive Abutment, Non-Engaging
• 06009544018384: Plastic Sleeve for Int. Hex Passive Abutment, Non-Engaging
• 06009544018377: Passive Abutment for Int. Hex, Non-Engaging
• 06009544018360: Titanium Cylinder for Ø6.0 Tri-Nex Passive Abutment, Non-Engaging
• 06009544018353: Plastic Sleeve for Ø6.0 Tri-Nex Passive Abutment, Non-Engaging