GUDID 06009544046486

Torx Titanium Screw for SP1, 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

• Primary Device ID: 06009544046486
• NIH Device Record Key: 85011076-7b5b-476a-b286-d851e2d1cea7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: TS-SP-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	06009544046486 [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: 2024-04-01
• Device Publish Date: 2024-03-22

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• 06009544037620 - NA: 2024-04-12 Handpiece Insertion Tool for Ø5.0 Tri-Nex, Guided Surgery
• 06009544044789 - N/A: 2024-04-10 Implant DC, Ø4.0 x 10mm
• 06009544044796 - N/A: 2024-04-10 Implant DC, Ø4.0 x 11mm
• 06009544039587 - N/A: 2024-04-03 Implant DC, Ø4.0 x 22mm
• 06009544039594 - N/A: 2024-04-03 Implant DC, Ø4.0 x 24mm
• 06009544046479 - N/A: 2024-04-01 Angulated Screw Channel Abutment, Engaging, for SP1