GUDID 06009544014089

Plastic Sleeve for IT Ø4.8 Interface Passive Abutment, Non-Engaging

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 06009544014089
• NIH Device Record Key: d0c9fa2d-e697-48b3-bab3-fb88f93aa2db
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ITS-PA-NEP
• 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	06009544014089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061169

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-01-23

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

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• 06009544050285 - NA: 2025-04-07 Bone Mill HP DC4 Ø5.0mm
• 06009544050292 - NA: 2025-04-07 Bone Mill HP DC5 Ø6.5mm
• 06009544050308 - NA: 2025-04-07 Bone Mill HP Int Hex Ø4.5mm
• 06009544050315 - NA: 2025-04-07 Bone Mill HP SP1 Ø5.5mm
• 06009544050322 - NA: 2025-04-07 Bone Mill HP Int Hex Ø5.5mm