ZYGAN® ZYGAN-57.5

GUDID 06009544039372

ExHex ZYGAN®, Ø4.3 x 57.5mm

SOUTHERN IMPLANTS (PTY) LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 06009544039372
• NIH Device Record Key: 830a6676-0916-4dd6-a241-9d18c3ee4a7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZYGAN®
• Version Model Number: ZYGAN-57.5
• Catalog Number: ZYGAN-57.5
• 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	06009544039372 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173343

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: 2021-11-30
• Device Publish Date: 2021-11-22

On-Brand Devices [ZYGAN®]

• 06009544039372: ExHex ZYGAN®, Ø4.3 x 57.5mm
• 06009544039365: ExHex ZYGAN®, Ø4.3 x 32.5mm