Z5c Z5m-50-12

GUDID 07640166760450

Monotype root-form dental implant made of Zirconia Familiy Z5c Size Z5c-50-12

Z SYSTEMS USA INCORPORATED

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 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 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 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: 07640166760450
• NIH Device Record Key: 9c8905cc-a241-4e73-9dc3-2d38922db4b3
• Commercial Distribution Discontinuation: 2016-10-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Z5c
• Version Model Number: Z5c-50-12
• Catalog Number: Z5m-50-12
• Company DUNS: 033691995
• Company Name: Z SYSTEMS USA INCORPORATED
• 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: true
• 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

Customer Support Contacts

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

Device Dimensions

• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
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• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640166760450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132881

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-25

On-Brand Devices [Z5c]

• 07640166760498: abutment made of Zirconia Familiy Z5c Size Z5c-A00s, straight, short
• 07640166760481: Abutment made of Zirconia Familiy Z5c Size Z5c-A15, 15° angulated, short
• 07640166760474: abutment made of Zirconia Familiy Z5c Size Z5c-A00, straight
• 07640166760467: Abutment made of Zirconia Familiy Z5c Size Z5c-A15, 15° angulated
• 07640166760450: Monotype root-form dental implant made of Zirconia Familiy Z5c Size Z5c-50-12
• 07640166760443: Monotype root-form dental implant made of Zirconia Familiy Z5c Size Z5c-50-10
• 07640166760436: Monotype root-form dental implant made of Zirconia Familiy Z5c Size Z5c-50-08
• 07640166760429: Monotype root-form dental implant made of Zirconia Familiy Z5c Size Z5m-40-12
• 07640166760412: endosseous root-form dental implant made of Zirconia Familiy Z5c Size Z5c-40-10 including Z5c-HC
• 07640166760405: endosseous root-form dental implant made of Zirconia Familiy Z5c Size Z5c-40-08 including Z5c-HC