SB16PH

GUDID 06009544019459

Plastic Sleeve for Ø4.0 Ex Hex Passive Abutment, Engaging

SOUTHERN IMPLANTS (PTY) LTD

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• Primary Device ID: 06009544019459
• NIH Device Record Key: 08d8d305-a704-43ec-87b3-54b5fb423ce4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SB16PH
• Version Model Number: 6009544019459
• 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: 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	06009544019459 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053478

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-28
• Device Publish Date: 2022-03-19

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

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• 06009544037613 - NA: 2024-04-12 Handpiece Insertion Tool for Ø4.3 Tri-Nex, Guided Surgery
• 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