Z5m(t) Z5m(t)-50-08

GUDID 07640166760535

Monotype root-form dental implant made of Zirconia Familiy Z5m(t) Size Z5m(t)-50-08

Z SYSTEMS USA INCORPORATED

Screw endosteal dental implant, one-piece

• Primary Device ID: 07640166760535
• NIH Device Record Key: 53f17d98-1026-4672-bc5e-9aa3a4830ba3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z5m(t)
• Version Model Number: Z5m(t)-50-08
• Catalog Number: Z5m(t)-50-08
• 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

• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640166760535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150021

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 [Z5m(t)]

• 07640166760559: Monotype root-form dental implant made of Zirconia Familiy Z5m(t) Size Z5m(t)-50-12
• 07640166760542: Monotype root-form dental implant made of Zirconia Familiy Z5m(t) Size Z5m(t)-50-10
• 07640166760535: Monotype root-form dental implant made of Zirconia Familiy Z5m(t) Size Z5m(t)-50-08
• 07640166760528: Monotype root-form dental implant made of Zirconia Familiy Z5m(t) Size Z5m(t)-40-12
• 07640166760511: Monotype root-form dental implant made of Zirconia Familiy Z5m(t) Size Z5m(t)-40-10
• 07640166760504: Monotype root-form dental implant made of Zirconia Familiy Z5m(t) Size Z5m(t)-40-08