GUDID 06009544004295

Anatomical Abutment, Engaging, for Ø5.0 Ex Hex, 2mm Cuff

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 06009544004295
• NIH Device Record Key: 2bcccd0a-22d3-44b6-9061-2cbe42d89213
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DBA2
• 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	06009544004295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163634

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-01-17

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

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• 06009544050582 - N/A: 2025-08-19 Implant DR SP1 Ø3.7x8mm
• 06009544050599 - N/A: 2025-08-19 Implant DR SP1 Ø3.7x11mm
• 06009544050605 - N/A: 2025-08-19 Implant DR SP1 Ø3.7x13mm
• 06009544050612 - N/A: 2025-08-19 Implant DR SP1 Ø3.7x16mm
• 06009544050629 - N/A: 2025-08-19 Implant DR SP1 Ø3.7x18mm
• 06009544050636 - N/A: 2025-08-19 Implant DR SP1 Ø3.7x20mm
• 06009544050650 - N/A: 2025-08-19 Implant DR SP1 Ø4.5x8mm