SB16PH

GUDID 06009544019459

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

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed

• 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

• 06009544038252 - NA: 2024-11-06 Screw Ti Hex Series L3.5mm
• 06009544039952 - N/A: 2024-11-01 Screw Titanium Hex 1 Series ø2.7 Head
• 06009544039969 - N/A: 2024-11-01 Screw Ti Hexed M1.4 NLT
• 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