Z5m lblc Z5m-40-08lb

GUDID 07640166760221

Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-40-08 lb

Z SYSTEMS USA INCORPORATED

Screw endosteal dental implant, one-piece

• Primary Device ID: 07640166760221
• NIH Device Record Key: 36c52002-1841-48a9-82b6-0ea841598623
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z5m lblc
• Version Model Number: Z5m-40-08lb
• Catalog Number: Z5m-40-08lb
• 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

Device Dimensions

• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640166760221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131701

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 lblc]

• 07640166760351: Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-40-12lc-25
• 07640166760344: Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-40-10 lc-25
• 07640166760337: Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-40-08lc-25
• 07640166760313: Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-36-10lc-25
• 07640166760306: Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-36-08lc-25
• 07640166760238: Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-40-10 lb
• 07640166760221: Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-40-08 lb
• 07640166760214: Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-36-10 lb
• 07640166760207: Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-36-08 lb