GUDID 06009544000105

Abutment Healing Int Hex PM 6.5x6

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 06009544000105
• NIH Device Record Key: d1ffc639-6bd1-40c6-bfe9-db9031b475e0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: HA-M65-PM-6
• 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	06009544000105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180465

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

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: 2025-07-17
• Device Publish Date: 2025-07-09

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