GUDID 06009544049685

Abutment Healing PKC Cen DC Ø3

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 06009544049685
• NIH Device Record Key: 2d201b1f-232c-4a70-8637-a95e94dd2975
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: HA-PKC1-DC3
• Company DUNS: 636239584
• Company Name: SOUTHERN IMPLANTS (PTY) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	06009544049685 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222457

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: 2025-01-15
• Device Publish Date: 2025-01-07

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

• 06009544047810 - N/A: 2025-11-25 Titanium Blank for Ø3.3 Provata®, Ø11.5mm
• 06009544047827 - N/A: 2025-11-25 Titanium Blank for Ø3.0 DC, Ø11.5mm
• 06009544047834 - N/A: 2025-11-25 Titanium Blank for Ø3.5/Ø4.0 DC, Ø11.5mm
• 06009544047841 - N/A: 2025-11-25 Titanium Blank for Ø5.0 DC , Ø11.5mm
• 06009544047858 - N/A: 2025-11-25 Titanium Blank for Ø3.5 Tri-Nex, Ø11.5mm
• 06009544047865 - N/A: 2025-11-25 Titanium Blank for Ø4.3 Tri-Nex, Ø11.5mm
• 06009544047872 - N/A: 2025-11-25 Titanium Blank for Ø5.0 Tri-Nex, Ø11.5mm
• 06009544047889 - N/A: 2025-11-25 Titanium Blank for Ø6.0 Tri-Nex, Ø11.5mm