IQ Implants SM420115

GUDID D777SM4201151

Smart Dental Implant 4.20x11.5mm, 3.75 Internal Hex Platform

I.Q. IMPLANTS LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: D777SM4201151
• NIH Device Record Key: f8fac414-627e-4891-a5ea-a61424ef38ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IQ Implants
• Version Model Number: SM420115
• Catalog Number: SM420115
• 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	D777SM4201151 [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: 2015-10-25

On-Brand Devices [IQ Implants]

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• D777SM6000131: Smart Dental Implant 6.0x13mm, 3.75 Internal Hex Platform
• D777SM6000101: Smart Dental Implant 6.0x10mm, 3.75 Internal Hex Platform
• D777SM6000081: Smart Dental Implant 6.0x8mm, 3.75 Internal Hex Platform
• D777SM5001151: Smart Dental Implant 5.0x11.5mm, 3.75 Internal Hex Platform
• D777SM5000161: Smart Dental Implant 5.0x16mm, 3.75 Internal Hex Platform
• D777SM5000131: Smart Dental Implant 5.0x13mm, 3.75 Internal Hex Platform
• D777SM5000101: Smart Dental Implant 5.0x10mm, 3.75 Internal Hex Platform
• D777SM5000081: Smart Dental Implant 5.0x8mm, 3.75 Internal Hex Platform
• D777SM4201151: Smart Dental Implant 4.20x11.5mm, 3.75 Internal Hex Platform
• D777SM4200161: Smart Dental Implant 4.20x16mm, 3.75 Internal Hex Platform
• D777SM4200131: Smart Dental Implant 4.20x13mm, 3.75 Internal Hex Platform
• D777SM4200101: Smart Dental Implant 4.20x10mm, 3.75 Internal Hex Platform
• D777SM4200081: Smart Dental Implant 4.20x8mm, 3.75 Internal Hex Platform
• D777SM3751151: Smart Dental Implant 3.75x11.5mm, 3.75 Internal Hex Platform
• D777SM3750161: Smart Dental Implant 3.75x16mm, 3.75 Internal Hex Platform
• 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