GUDID 06009544016700

Compact Conical Abutment for Int. Hex, Ø4.8 x 5mm Cuff

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 06009544016700
• NIH Device Record Key: 5268e49e-dca9-454f-ab51-578779436ebf
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: MC-M-5
• 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	06009544016700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180465

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-01-21

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

• 06009544041450 - N/A: 2025-01-31 Scan Flag Ti ø3.3 PRO
• 06009544038306 - NA: 2025-01-30 Handpiece Insertion Tool for Ø4.3 Tri-Nex Co-Axis Guided Surgery
• 06009544038955 - NA: 2025-01-30 Sleeve Guided Surgery 06.2 x 4mm
• 06009544048930 - N/A: 2025-01-28 Instr Drill Ext GS ø5.1 Offset 10.5
• 06009544049074 - N/A: 2025-01-28 Insertion Tool Int Hex BG
• 06009544049098 - N/A: 2025-01-28 Instr H/P Insert Tool PRO3 BG
• 06009544049104 - N/A: 2025-01-28 Instr H/P Insert Tool PRO3 BGN
• 06009544049111 - N/A: 2025-01-28 Insertion Tool Int Hex BGN