GUDID 06009544037736

Compact Conical Abutment for Ø3.3 Provata®, Ø4.8 x 5mm Cuff

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 06009544037736
• NIH Device Record Key: 5281d26b-1cba-4d14-9c05-f2326e6cb1d9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: MC-3M-5
• Company DUNS: 636239584
• Company Name: SOUTHERN IMPLANTS (PTY) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	06009544037736 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222457

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-31
• Device Publish Date: 2023-03-23

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

• 06009544037491 - N/A: 2024-06-18 Screw PA Abut PRO M1.6 Titanium
• 06009544038276 - N/A: 2024-06-18 Screw PA Abut PRO M16 Brass
• 06009544045274 - N/A: 2024-06-07 Implant Inverta MSc DC30 Ø3.75x8
• 06009544045281 - N/A: 2024-06-07 Implant Inverta MSc DC30 Ø3.75x10
• 06009544045298 - N/A: 2024-06-07 Implant Inverta MSc DC30 Ø3.75x13
• 06009544045304 - N/A: 2024-06-07 Implant Inverta MSc DC30 Ø3.75x11.5
• 06009544045311 - N/A: 2024-06-07 Implant Inverta MSc DC30 Ø3.75x15
• 06009544045328 - N/A: 2024-06-07 Implant Inverta MSc DC35 Ø4.5x8