Implant 4.1*5

GUDID 07290112280664

Implant 4.1*5

DENTACK IMPLANTS LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 07290112280664
• NIH Device Record Key: 9e708f76-89e5-4ce8-a3fa-a60e707dc0f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Implant 4.1*5
• Version Model Number: EDI-4105
• Company DUNS: 514897185
• Company Name: DENTACK IMPLANTS LTD
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: +97297660379
• Email: info@pyramidion-is.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290112280664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180859

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[07290112280664]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-27

Devices Manufactured by DENTACK IMPLANTS LTD

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• 07290112280855 - Expansion tool EX-screw+wrench short - Assy: 2019-12-20 Expansion tool EX-screw+wrench short - Assy
• 07290112280664 - Implant 4.1*5: 2019-03-11Implant 4.1*5
• 07290112280664 - Implant 4.1*5: 2019-03-11 Implant 4.1*5
• 07290112280671 - Straight MU Abutment: 2019-03-11 Straight MU Abutment
• 07290112280688 - Multi Unit Abutment for EX: 2019-03-11 Multi Unit Abutment for EX
• 07290112280695 - Straight MU Abutment: 2019-03-11 Straight MU Abutment
• 07290112280701 - Multi Unit Abutment for EX: 2019-03-11 Multi Unit Abutment for EX
• 07290112280718 - Straight MU Abutment: 2019-03-11 Straight MU Abutment