ZAGA™ CH-ZT-55.0

GUDID 06009544034841

Straumann® Zygomatic Implant, ZAGA™ Round Ø 4.3mm, L 55mm, Ti

SOUTHERN IMPLANTS (PTY) LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 06009544034841
• NIH Device Record Key: 9ab3c217-3f69-43f1-aa8f-47dad313b021
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZAGA™
• Version Model Number: CH-ZT-55.0
• Catalog Number: CH-ZT-55.0
• 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	06009544034841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192651

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: 2021-12-01
• Device Publish Date: 2021-11-23

On-Brand Devices [ZAGA™]

• 06009544034735: Straumann® Zygomatic Implant, ZAGA™ Flat Ø 4.3mm, L 50mm, Ti
• 06009544034728: Straumann® Zygomatic Implant, ZAGA™ Flat Ø 4.3mm, L 47.5mm, Ti
• 06009544034711: Straumann® Zygomatic Implant, ZAGA™ Flat Ø 4.3mm, L 45mm, Ti
• 06009544034704: Straumann® Zygomatic Implant, ZAGA™ Flat Ø 4.3mm, L 42.5mm, Ti
• 06009544034698: Straumann® Zygomatic Implant, ZAGA™ Flat Ø 4.3mm, L 40mm, Ti
• 06009544034681: Straumann® Zygomatic Implant, ZAGA™ Flat Ø 4.3mm, L 37.5mm, Ti
• 06009544034674: Straumann® Zygomatic Implant, ZAGA™ Flat Ø 4.3mm, L 35mm, Ti
• 06009544034667: Straumann® Zygomatic Implant, ZAGA™ Flat Ø 4.3mm, L 30mm, Ti
• 06009544034650: Straumann® Zygomatic Implant, ZAGA™ Flat Ø 4.3mm, L 32.5mm, Ti
• 06009544039266: Straumann® Zygomatic Implant, ZAGA™ Flat Ø 4.3mm, L 57.5mm, Ti
• 06009544039259: Straumann® Zygomatic Implant, ZAGA™ Flat Ø 4.3mm, L 55mm, Ti
• 06009544039235: Straumann® Zygomatic Implant, ZAGA™ Round Ø 4.3mm, L 57.5mm, Ti
• 06009544039228: Straumann® Zygomatic Implant, ZAGA™ Round Ø 4.3mm, L 32.5mm, Ti
• 06009544039211: Straumann® Zygomatic Implant, ZAGA™ Round Ø 4.3mm, L 30mm, Ti
• 06009544034858: Straumann® Zygomatic Implant, ZAGA™ Round Ø 4.3mm, L 42.5mm, Ti
• 06009544034841: Straumann® Zygomatic Implant, ZAGA™ Round Ø 4.3mm, L 55mm, Ti
• 06009544034834: Straumann® Zygomatic Implant, ZAGA™ Round Ø 4.3mm, L 52.5mm, Ti
• 06009544034827: Straumann® Zygomatic Implant, ZAGA™ Round Ø 4.3mm, L 50mm, Ti
• 06009544034797: Straumann® Zygomatic Implant, ZAGA™ Round Ø 4.3mm, L 47.5mm, Ti
• 06009544034780: Straumann® Zygomatic Implant, ZAGA™ Round Ø 4.3mm, L 45mm, Ti
• 06009544034773: Straumann® Zygomatic Implant, ZAGA™ Round Ø 4.3mm, L 40mm, Ti
• 06009544034766: Straumann® Zygomatic Implant, ZAGA™ Round Ø 4.3mm, L 37.5mm, Ti
• 06009544034742: Straumann® Zygomatic Implant, ZAGA™ Flat Ø 4.3mm, L 52.5mm, Ti