GUDID 06009544006831

Equator Overdenture Abutment for Ø5.0 DC, 6mm Cuff

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 06009544006831
• NIH Device Record Key: 93962788-b09b-41f8-933b-00c1f677b020
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: EQ-DC5-6
• 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	06009544006831 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163060

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: 2019-01-07

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

• 06009544000105 - NA: 2025-07-17 Abutment Healing Int Hex PM 6.5x6
• 06009544050438 - N/A: 2025-07-17 Abutment Healing SP1 ø3.8x2.5mm
• 06009544050445 - N/A: 2025-07-17 Abutment Healing SP1 ø3.8x3.5mm
• 06009544050452 - N/A: 2025-07-17 Abutment Healing SP1 ø3.8x4.5mm
• 06009544050469 - N/A: 2025-07-17 Abutment Healing SP1 ø3.8x5.5mm
• 06009544050476 - N/A: 2025-07-17 Abutment Healing SP1 ø3.8x6.5mm
• 06009544050483 - N/A: 2025-07-17 Abutment Healing SP1 ø4.5x6.5mm
• 06009544050490 - N/A: 2025-07-17 Abutment Healing SP1 ø5.0x6.5mm