GUDID 06009544002499

Scanning Abutment, Engaging, for Ø5.0 Tri-Nex

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 06009544002499
• NIH Device Record Key: 3a71090b-08cc-4fb6-9c2a-8bab0956c8ae
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CIA-EL-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	06009544002499 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070905

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[06009544002499]

Moist Heat or Steam Sterilization

[06009544002499]

Moist Heat or Steam Sterilization

[06009544002499]

Moist Heat or Steam Sterilization

[06009544002499]

Moist Heat or Steam Sterilization

[06009544002499]

Moist Heat or Steam Sterilization

[06009544002499]

Moist Heat or Steam Sterilization

[06009544002499]

Moist Heat or Steam Sterilization

[06009544002499]

Moist Heat or Steam Sterilization

[06009544002499]

Moist Heat or Steam Sterilization

[06009544002499]

Moist Heat or Steam Sterilization

[06009544002499]

Moist Heat or Steam Sterilization

[06009544002499]

Moist Heat or Steam Sterilization

[06009544002499]

Moist Heat or Steam Sterilization

[06009544002499]

Moist Heat or Steam Sterilization

[06009544002499]

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

• 06009544050742 - NA: 2025-08-07 Guide Screw Remover Ø3.3 Provata
• 06009544050759 - NA: 2025-08-07 Instrument, I-SR6 Screw Remover Guide for SP1
• 06009544050766 - N/A: 2025-08-07 Instrument, Guided Surgery Fixture Mount for SP1
• 06009544050773 - N/A: 2025-08-07 Instrument, Guided Surgery Fixture Mount for SP1, Long
• 06009544050391 - N/A: 2025-08-06 Spade Twist Drill for SP1, 02.0mm
• 06009544050407 - N/A: 2025-08-06 Spade Twist Drill for SP1, 02.0mm, Long
• 06009544050414 - N/A: 2025-08-06 Spade Twist Drill for SP1, 02.0mm
• 06009544050421 - N/A: 2025-08-06 Spade Twist Drill for SP1, 02.0mm, Long