013

GUDID 06009544021971

Titanium Abutment, Non-Engaging, for Ø6.0 Tri-Nex, 1mm Cuff

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 06009544021971
• NIH Device Record Key: a1ff0bd1-64ab-44fa-a87c-f768666524fa
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: TC-NL-60-1
• Catalog Number: 013
• 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	06009544021971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070905

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: 2019-01-09

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

• 06009544000105 - NA: 2025-07-17 Abutment Healing Int Hex PM 6.5x6
• 06009544050438 - N/A: 2025-07-17 Abutment Healing SP1 ø3.8x2.5mm
• 06009544050445 - N/A: 2025-07-17 Abutment Healing SP1 ø3.8x3.5mm
• 06009544050452 - N/A: 2025-07-17 Abutment Healing SP1 ø3.8x4.5mm
• 06009544050469 - N/A: 2025-07-17 Abutment Healing SP1 ø3.8x5.5mm
• 06009544050476 - N/A: 2025-07-17 Abutment Healing SP1 ø3.8x6.5mm
• 06009544050483 - N/A: 2025-07-17 Abutment Healing SP1 ø4.5x6.5mm
• 06009544050490 - N/A: 2025-07-17 Abutment Healing SP1 ø5.0x6.5mm