Z5-BL Z5-BL-3610

GUDID 07640166768494

Implant + TP-SNS + BL-HC

Z-Systems AG

Screw endosteal dental implant, two-piece

• Primary Device ID: 07640166768494
• NIH Device Record Key: 3836ea80-9755-49e0-8bbe-be3f6d2d7e46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z5-BL
• Version Model Number: Z5-BL-3610
• Catalog Number: Z5-BL-3610
• Company DUNS: 483189556
• Company Name: Z-Systems AG
• 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: true
• 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

Customer Support Contacts

• Phone: (877) 874 9407
• Email: contact@zsystems.com
• Phone: (877) 874 9407
• Email: contact@zsystems.com
• Phone: (877) 874 9407
• Email: contact@zsystems.com
• Phone: (877) 874 9407
• Email: contact@zsystems.com
• Phone: (877) 874 9407
• Email: contact@zsystems.com
• Phone: (877) 874 9407
• Email: contact@zsystems.com
• Phone: (877) 874 9407
• Email: contact@zsystems.com
• Phone: (877) 874 9407
• Email: contact@zsystems.com
• Phone: (877) 874 9407
• Email: contact@zsystems.com
• Phone: (877) 874 9407
• Email: contact@zsystems.com
• Phone: (877) 874 9407
• Email: contact@zsystems.com
• Phone: (877) 874 9407
• Email: contact@zsystems.com
• Phone: (877) 874 9407
• Email: contact@zsystems.com
• Phone: (877) 874 9407
• Email: contact@zsystems.com
• Phone: (877) 874 9407
• Email: contact@zsystems.com

Device Dimensions

• Length: 10 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640166768494 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200386

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: 2024-02-20
• Device Publish Date: 2024-02-12

On-Brand Devices [Z5-BL]

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• 07640166768494: Implant + TP-SNS + BL-HC
• 07640166768463: Implant + TP-SNS + BL-HC
• 07640166760856: Implant + TP-SNS + BL-HC
• 07640166760849: Implant + TP-SNS + BL-HC
• 07640166760832: Implant + TP-SNS + BL-HC
• 07640166760825: Implant + TP-SNS + BL-HC
• 07640166760818: Implant + TP-SNS + BL-HC
• 07640166760801: Implant + TP-SNS + BL-HC