Z5m Z5m-36-10

GUDID 07640166760009

Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-36-10

Z SYSTEMS USA INCORPORATED

Screw endosteal dental implant, one-piece

• Primary Device ID: 07640166760009
• NIH Device Record Key: f035e627-7968-4689-91da-7c3d59c51835
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z5m
• Version Model Number: Z5m-36-10
• Catalog Number: Z5m-36-10
• 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: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com
• Phone: +41623886969
• Email: support@zsystems.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640166760009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120793

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-02

On-Brand Devices [Z5m]

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• 07640166760146: Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-40-12
• 07640166760139: Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-36-12
• 07640166760122: Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-36-08
• 07640166760115: Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-50-13
• 07640166760108: Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-50-11 reduced collar
• 07640166760092: Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-50-11
• 07640166760085: Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-50-10 - reduced collar
• 07640166760078: Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-50-10
• 07640166760061: Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-50-08
• 07640166760054: Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-40-13
• 07640166760047: Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-40-11
• 07640166760030: Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-40-10
• 07640166760023: Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-40-08
• 07640166760016: Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-36-11
• 07640166760009: Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-36-10