GUDID 06009544030973

Titanium Abutment Base for Ø5.0 Tri-Nex, Non-Engaging

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 06009544030973
• NIH Device Record Key: c6de25c2-a09e-42bc-adc4-a1a963e8b428
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: TIB-NL-50
• 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: false
• 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	06009544030973 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070905
• Premarket Notification: K193084

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

[06009544030973]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-01-09

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

• 06009544040064 - N/A: 2025-05-05 Instr H/P Oct Int Drive GS
• 06009544012115 - N/A: 2025-05-02 Converter and Extention Instr
• 06009544039990 - N/A: 2025-05-02 Instrument Space Maintainer CC 4.8x6
• 06009544040774 - N/A: 2025-05-02 O-Ring DC3 Insertion Tools MP5
• 06009544050353 - NA: 2025-05-01 Compact Conical Abutment for 17° Ø4 ExHex Ø4.8x3mm
• 06009544050360 - NA: 2025-05-01 Compact Conical Abutment for 17° Ø4 ExHex Ø4.8x4mm
• 06009544048947 - ZAGA™: 2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 30.0mm
• 06009544048954 - ZAGA™: 2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 32.5mm