GUDID 06009544041658

Torx Titanium M1.4 Screw, Angulated Screw Channel

SOUTHERN IMPLANTS (PTY) LTD

Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw

• Primary Device ID: 06009544041658
• NIH Device Record Key: fbbe387a-523a-48d1-96ea-0ea3f6cfee27
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: TST1-ASC
• 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	06009544041658 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230873

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: 2023-08-31
• Device Publish Date: 2023-08-23

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

• 06009544037491 - N/A: 2024-06-18 Screw PA Abut PRO M1.6 Titanium
• 06009544038276 - N/A: 2024-06-18 Screw PA Abut PRO M16 Brass
• 06009544045274 - N/A: 2024-06-07 Implant Inverta MSc DC30 Ø3.75x8
• 06009544045281 - N/A: 2024-06-07 Implant Inverta MSc DC30 Ø3.75x10
• 06009544045298 - N/A: 2024-06-07 Implant Inverta MSc DC30 Ø3.75x13
• 06009544045304 - N/A: 2024-06-07 Implant Inverta MSc DC30 Ø3.75x11.5
• 06009544045311 - N/A: 2024-06-07 Implant Inverta MSc DC30 Ø3.75x15
• 06009544045328 - N/A: 2024-06-07 Implant Inverta MSc DC35 Ø4.5x8