NobelClinician® 101560

GUDID 07332747125153

NobelClinician 3.1 for Windows 32-bit

Nobel Biocare AB

General-purpose dental x-ray system application software

• Primary Device ID: 07332747125153
• NIH Device Record Key: d564276b-e8e1-4fd0-9b6b-7c69eef665af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NobelClinician®
• Version Model Number: 3.1
• Catalog Number: 101560
• Company DUNS: 353939929
• Company Name: Nobel Biocare AB
• Device Count: 1
• DM Exempt: true
• 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: 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: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747125153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163122

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-31
• Device Publish Date: 2017-02-27

On-Brand Devices [NobelClinician®]

• 07332747128970: NobelClinician 3.2 for MAC
• 07332747128963: NobelClinician 3.2 for Windows 64-bit
• 07332747125177: NobelClinician 3.1 for MAC
• 07332747125160: NobelClinician 3.1 for Windows 64-bit
• 07332747125153: NobelClinician 3.1 for Windows 32-bit
• 07332747124972: NobelClinician 2.8 for Windows MAC
• 07332747124958: NobelClinician 2.8 for Windows 64-bit
• 07332747124941: NobelClinician 2.8 for Windows 32-bit