IQ Implants SM320010

GUDID D777SM3200101

Smart Dental Implant 3.30x10mm, 3.75mm Internal Hex Platform

I.Q. IMPLANTS LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: D777SM3200101
• NIH Device Record Key: 3b967a2f-47f3-42ed-bb97-3465fc8346c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IQ Implants
• Version Model Number: SM320010
• Catalog Number: SM320010
• Company DUNS: 534177824
• Company Name: I.Q. 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: 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: +972547877708
• Email: info@iqimplants.com
• Phone: +972547877708
• Email: info@iqimplants.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D777SM3200101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130829

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: 2015-10-23

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• D777SM3750131: Smart Dental Implant 3.75x13mm, 3.75 Internal Hex Platform
• D777SM3750101: Smart Dental Implant 3.75x10mm, 3.75 Internal Hex Platform
• D777SM3750081: Smart Dental Implant 3.75x8mm, 3.75 Internal Hex Platform
• D777SM3201151: Smart Dental Implant 3.30x11.5, 3.75mm Internal Hex Platform
• D777SM3200161: Smart Dental Implant 3.30x16mm, 3.75 Internal Hex Platform
• D777SM3200131: Smart Dental Implant 3.30x13mm, 3.75 Internal Hex Platform
• D777SM3200101: Smart Dental Implant 3.30x10mm, 3.75mm Internal Hex Platform
• D777SM3200081: Smart Dental Implant 3.30x8mm, 3.75mm Internal Hex Platform