INVERTA® IV-EX4012D-5011

GUDID 06009544027447

INVERTA®, Ø4.0 ExHex 12° CO-AXIS®, Ø5.0 x 11.5mm

SOUTHERN IMPLANTS (PTY) LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 06009544027447
• NIH Device Record Key: fc07965c-904c-4056-8469-c2a91e4f0d01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INVERTA®
• Version Model Number: IV-EX4012D-5011
• Catalog Number: IV-EX4012D-5011
• Company DUNS: 636239584
• Company Name: SOUTHERN IMPLANTS (PTY) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	06009544027447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181850

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: 2021-11-30
• Device Publish Date: 2021-11-22

On-Brand Devices [INVERTA®]

• 06009544038443: INVERTA®, Ø4.0 DC, Ø5.0 x 8mm
• 06009544036807: INVERTA®, Ø5.0 DC, Ø6.0 x 18mm
• 06009544036791: INVERTA®, Ø5.0 DC, Ø6.0 x 15mm
• 06009544036784: INVERTA®, Ø5.0 DC, Ø6.0 x 13mm
• 06009544036777: INVERTA®, Ø5.0 DC, Ø6.0 x 11.5mm
• 06009544036760: INVERTA®, Ø5.0 DC, Ø6.0 x 10mm
• 06009544034506: INVERTA®, Ø4.0 DC, Ø5.0 x 18mm
• 06009544034490: INVERTA®, Ø4.0 DC, Ø5.0 x 15mm
• 06009544034483: INVERTA®, Ø4.0 DC, Ø5.0 x 13mm
• 06009544034476: INVERTA®, Ø4.0 DC, Ø5.0 x 11.5mm
• 06009544034469: INVERTA®, Ø4.0 DC, Ø5.0 x 10mm
• 06009544029687: INVERTA®, Ø3.5 DC 12° CO-AXIS®, Ø4.5 x 13mm
• 06009544029663: INVERTA®, Ø3.5 DC 12° CO-AXIS®, Ø4.5 x 11.5mm
• 06009544029656: INVERTA®, Ø3.5 DC 12° CO-AXIS®, Ø4.5 x 18mm
• 06009544036753: INVERTA®, Ø5.2 ExHex, Ø6.0 x 18mm
• 06009544036746: INVERTA®, Ø5.2 ExHex, Ø6.0 x 15mm
• 06009544036739: INVERTA®, Ø5.2 ExHex, Ø6.0 x 13mm
• 06009544036722: INVERTA®, Ø5.2 ExHex, Ø6.0 x 11.5mm
• 06009544036715: INVERTA®, Ø5.2 ExHex, Ø6.0 x 10mm
• 06009544036449: IV-EX5212D-6018
• 06009544036432: INVERTA®, Ø5.2 ExHex 12° CO-AXIS®, Ø6.0 x 15mm
• 06009544036425: INVERTA®, Ø5.2 ExHex 12° CO-AXIS®, Ø6.0 x 13mm
• 06009544036418: INVERTA®, Ø5.2 ExHex 12° CO-AXIS®, Ø6.0 x 11.5mm
• 06009544034612: INVERTA®, Ø3.5 ExHex, Ø4.5 x 18mm
• 06009544034605: INVERTA®, Ø3.5 ExHex, Ø4.5 x 11.5mm
• 06009544034599: INVERTA®, Ø4.0 ExHex, Ø5.0 x 18mm
• 06009544034582: INVERTA®, Ø4.0 ExHex, Ø5.0 x 15mm
• 06009544034575: INVERTA®, Ø4.0 ExHex, Ø5.0 x 13mm
• 06009544034568: INVERTA®, Ø4.0 ExHex, Ø5.0 x 11.5mm
• 06009544034551: INVERTA®, Ø4.0 ExHex, Ø5.0 x 10mm
• 06009544034544: INVERTA®, Ø3.5 ExHex, Ø4.5 x 15mm
• 06009544034537: INVERTA®, Ø3.5 ExHex, Ø4.5 x 13mm
• 06009544034520: INVERTA®, Ø3.5 ExHex, Ø4.5 x 10mm
• 06009544028345: INVERTA®, Ø4.2 ExHex 12° CO-AXIS®, Ø5.0 x 18mm
• 06009544028338: INVERTA®, Ø4.2 ExHex 12° CO-AXIS®, Ø5.0 x 15mm
• 06009544028321: INVERTA®, Ø4.2 ExHex 12° CO-AXIS®, Ø5.0 x 13mm
• 06009544028314: INVERTA®, Ø4.2 ExHex 12° CO-AXIS®, Ø5.0 x 11.5mm
• 06009544027492: INVERTA®, Ø4.0 ExHex 12° CO-AXIS®, Ø5.0 x 18mm
• 06009544027478: INVERTA®, Ø4.0 ExHex 12° CO-AXIS®, Ø5.0 x 15mm
• 06009544027454: INVERTA®, Ø4.0 ExHex 12° CO-AXIS®, Ø5.0 x 13mm
• 06009544027447: INVERTA®, Ø4.0 ExHex 12° CO-AXIS®, Ø5.0 x 11.5mm
• 06009544027386: INVERTA®, Ø3.5 ExHex 12° CO-AXIS®, Ø4.5 x 18mm
• 06009544027379: INVERTA®, Ø3.5 ExHex 12° CO-AXIS®, Ø4.5 x 15mm
• 06009544027362: INVERTA®, Ø3.5 ExHex 12° CO-AXIS®, Ø4.5 x 13mm
• 06009544027355: INVERTA®, Ø3.5 ExHex 12° CO-AXIS®, Ø4.5 x 11.5mm
• 06009544036289: Drill Taper Inverta ø6.0x18
• 06009544036272: Drill Taper Inverta ø6.0x15
• 06009544036258: Drill Taper Inverta ø6.0x11.5
• 06009544036241: Drill Taper Inverta ø6.0x10
• 06009544033806: D-IV3715