Tri-Nex Co-Axis™

GUDID 06009544009306

Tri-Nex Tapered Implant, 12° Co-Axis™, Ø4.3 x 16.5mm

SOUTHERN IMPLANTS (PTY) LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 06009544009306
• NIH Device Record Key: 938742f7-db53-4634-b303-378d2bdd785b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tri-Nex Co-Axis™
• Version Model Number: IA43-12D-16
• 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	06009544009306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070905

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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: 2019-02-08
• Device Publish Date: 2019-01-08

On-Brand Devices [Tri-Nex Co-Axis™]

• 06009544009344: Tri-Nex Tapered Implant, 12° Co-Axis™, Ø5.0 x 16.5mm
• 06009544009337: Tri-Nex Tapered Implant, 12° Co-Axis™, Ø5.0 x 13.5mm
• 06009544009320: Tri-Nex Tapered Implant, 12° Co-Axis™, Ø5.0 x 12mm
• 06009544009313: Tri-Nex Tapered Implant, 12° Co-Axis™, Ø5.0 x 10.5mm
• 06009544009306: Tri-Nex Tapered Implant, 12° Co-Axis™, Ø4.3 x 16.5mm
• 06009544009290: Tri-Nex Tapered Implant, 12° Co-Axis™, Ø4.3 x 13.5mm
• 06009544009283: Tri-Nex Tapered Implant, 12° Co-Axis™, Ø4.3 x 12mm
• 06009544009276: Tri-Nex Tapered Implant, 12° Co-Axis™, Ø4.3 x 10.5mm