Z5m Z5m-36-08

GUDID 07640166760122

Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-36-08

Z SYSTEMS USA INCORPORATED

Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece

• Primary Device ID: 07640166760122
• NIH Device Record Key: 4c340055-eee2-45ef-9490-250645249c39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z5m
• Version Model Number: Z5m-36-08
• Catalog Number: Z5m-36-08
• 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: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com
• Phone: (877) 874 9407
• Email: usa@zsystems.com

Device Dimensions

• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 3.6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640166760122 [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: 6
• Public Version Date: 2018-07-17
• Device Publish Date: 2017-02-06

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