Provata Co-Axis™

GUDID 06009544026860

Internal Hex 12° Co-Axis Implant, Ø4.0 x 18mm

SOUTHERN IMPLANTS (PTY) LTD

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 06009544026860
• NIH Device Record Key: 37326b0f-97b4-45cd-9765-fe153b41fbcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provata Co-Axis™
• Version Model Number: PRO12D418
• 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	06009544026860 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180465

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: 2019-01-10

On-Brand Devices [Provata Co-Axis™]

• 06009544026921: Internal Hex 12° Co-Axis Implant, Ø5.0 x 18mm
• 06009544026914: Internal Hex 12° Co-Axis Implant, Ø5.0 x 15mm
• 06009544026907: Internal Hex 12° Co-Axis Implant, Ø5.0 x 13mm
• 06009544026891: Internal Hex 12° Co-Axis Implant, Ø5.0 x 11.5mm
• 06009544026884: Internal Hex 12° Co-Axis Implant, Ø5.0 x 10mm
• 06009544026877: Internal Hex 12° Co-Axis Implant, Ø5.0 x 8.5mm
• 06009544026860: Internal Hex 12° Co-Axis Implant, Ø4.0 x 18mm
• 06009544026853: Internal Hex 12° Co-Axis Implant, Ø4.0 x 15mm
• 06009544026846: Internal Hex 12° Co-Axis Implant, Ø4.0 x 13mm
• 06009544026839: Internal Hex 12° Co-Axis Implant, Ø4.0 x 11.5mm
• 06009544026822: Internal Hex 12° Co-Axis Implant, Ø4.0 x 10mm
• 06009544026815: Internal Hex 12° Co-Axis Implant, Ø4.0 x 8.5mm