GUDID 06009544021520

Cosmetic Abutment for Ø4.3 Tri-Nex

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 06009544021520
• NIH Device Record Key: 6a9db774-779b-4161-b66a-07ddfa17f563
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: TCA-EL-43
• 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	06009544021520 [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

• 06009544048589 - N/A: 2024-09-03 Implant SP1 Ø4.0x10mm
• 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