IPS CaseDesigner® 300011

GUDID 07332747185829

IPS CaseDesigner 2.3 Win 64-bit

Nobel Biocare AB

Dental treatment application software

• Primary Device ID: 07332747185829
• NIH Device Record Key: eef84be2-2fe9-4a9b-9e9b-b4d5d5981435
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IPS CaseDesigner®
• Version Model Number: 2.3
• Catalog Number: 300011
• Company DUNS: 353939929
• Company Name: Nobel Biocare AB
• 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: false
• 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: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747185829 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200810

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-09
• Device Publish Date: 2021-12-01

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• 07332747178241: IPS CaseDesigner 2.1 Win 64-bit
• 07332747181920: IPS CaseDesigner 2.2 Mac
• 07332747181913: IPS CaseDesigner 2.2 Win 64-bit
• 07332747185836: IPS CaseDesigner 2.3 Mac
• 07332747185829: IPS CaseDesigner 2.3 Win 64-bit
• 07332747197525: IPS CaseDesigner 2.4 Win 64-bit
• 07332747197518: IPS CaseDesigner 2.4 Mac
• 07332747199079: IPS CaseDesigner 2.5 for MAC
• 07332747199062: IPS CaseDesigner 2.5 for Windows 64-bit
• 07332747202878: IPS CaseDesigner 2.6 for MAC
• 07332747202861: IPS CaseDesigner 2.6 for Windows 64-bit