Tri-Max®

GUDID 06009544022497

Implant, Tri-Max®, Ø8.0 x 9mm

SOUTHERN IMPLANTS (PTY) LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 06009544022497
• NIH Device Record Key: 99083bcb-060f-4467-b783-06e9fede577c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tri-Max®
• Version Model Number: TRI-MAX8-9
• 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	06009544022497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071161

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: 2019-02-11
• Device Publish Date: 2019-01-11

On-Brand Devices [Tri-Max®]

• 06009544022527: Implant, Tri-Max®, Ø9.0 x 9mm
• 06009544022510: Implant, Tri-Max®, Ø9.0 x 7mm
• 06009544022503: Implant, Tri-Max®, Ø9.0 x 11mm
• 06009544022497: Implant, Tri-Max®, Ø8.0 x 9mm
• 06009544022480: Implant, Tri-Max®, Ø8.0 x 7mm
• 06009544022473: Implant, Tri-Max®, Ø8.0 x 11mm
• 06009544022466: Implant, Tri-Max®, Ø7.0 x 9mm
• 06009544022459: Implant, Tri-Max®, Ø7.0 x 7mm
• 06009544022442: Implant, Tri-Max®, Ø7.0 x 11mm