GUDID 06009544009269

Ext. Hex Cylindrical Implant, Ø4.0 x 8.5mm

SOUTHERN IMPLANTS (PTY) LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 06009544009269
• NIH Device Record Key: c9c4213b-0f6e-481f-a973-9ddc9c8594aa
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: I4B8.5
• 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	06009544009269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003620

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: 2019-02-22
• Device Publish Date: 2019-01-22

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

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• 06009544048596 - N/A: 2024-09-03 Implant SP1 Ø4.0x11mm
• 06009544048619 - N/A: 2024-09-03 Implant SP1 Ø4.0x15mm
• 06009544048626 - N/A: 2024-09-03 Implant SP1 Ø4.0x18mm
• 06009544048633 - N/A: 2024-09-03 Implant SP1 Ø4.0x20mm
• 06009544048640 - N/A: 2024-09-03 Implant SP1 Ø4.0x22mm
• 06009544048657 - N/A: 2024-09-03 Implant SP1 Ø4.0x24mm
• 06009544039785 - N/A: 2024-08-30 Cortical Perforator Drill for Guided Surgery ø4.1