JDIcon Ultra S ISSA

GUDID 08055510176402

Prosthetic Screw Angulated JDIcon Ultra S

J DENTAL CARE SRL

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system

• Primary Device ID: 08055510176402
• NIH Device Record Key: 4eb3d871-5f37-4f81-bba5-664a1129717d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JDIcon Ultra S
• Version Model Number: Prosthetic Screw Angulated JDIcon Ultra S
• Catalog Number: ISSA
• Company DUNS: 428716597
• Company Name: J DENTAL CARE SRL
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com
• Phone: +39059454255
• Email: g.grandi@jdentalcare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08055510176402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182081

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

[08055510176402]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-06
• Device Publish Date: 2020-07-29

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• 08055510176280: Cover Screw JDIcon Ultra S
• 08055510176273: JDIcon Ultra S D 2.75 L 15
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• 08055510176259: JDIcon Ultra S D 2.75 L 11.5
• 08055510176242: JDIcon Ultra S D 2.75 L 10
• 08055510176549: Ball Abutment H 5.0 JDIcon Ultra S
• 08055510176532: Ball Abutment H 3.0 JDIcon Ultra S
• 08055510176525: Ball Abutment H 1.5 JDIcon Ultra S
• 08055510176471: Straight Abutment D 4.0 H 4.0 JDIcon Ultra S
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• 08055510176433: GP Abutment D 4.0 JDIcon Ultra S
• 08055510176426: GP Abutment D 3.2 JDIcon Ultra S
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• 08055510176402: Prosthetic Screw Angulated JDIcon Ultra S
• 08055510176396: Prosthetic Screw JDIcon Ultra S
• 08055510176341: Healing Abutment D 4.0 H 7.0 JDIcon Ultra S
• 08055510176334: Healing Abutment D 4.0 H 5.0 JDIcon Ultra S
• 08055510176327: Healing Abutment D 4.0 H 3.0 JDIcon Ultra S
• 08055510176310: Healing Abutment D 3.2 H 7.0 JDIcon Ultra S
• 08055510176303: Healing Abutment D 3.2 H 5.0 JDIcon Ultra S
• 08055510176297: Healing Abutment D 3.2 H 3.0 JDIcon Ultra S
• 08056591012368: Implant Replica CAD CAM New JDIcon Ultra S
• 08055510176501: Implant Replica CAD CAD JDIcon Ultra S
• 08055510176457: Wax-Up Abutment Engaging JDIcon Ultra S
• 08055510176518: Pre-milled Abutment Blank JDIcon Ultra S
• 08056591013075: Cobalt-Chrome Abutment Engaging JDIcon Ultra S