DTX Studio™ Implant 300843

GUDID 07332747158809

DTX Studio Implant 3.3 for Mac

Nobel Biocare AB

Dental treatment application software

• Primary Device ID: 07332747158809
• NIH Device Record Key: fb30c779-c661-48a1-a1bd-c777936e8c0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DTX Studio™ Implant
• Version Model Number: 3.3
• Catalog Number: 300843
• 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: 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	07332747158809 [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: 2
• Public Version Date: 2019-05-31
• Device Publish Date: 2018-08-07

On-Brand Devices [DTX Studio™ Implant]

• 07332747158809: DTX Studio Implant 3.3 for Mac
• 07332747158793: DTX Studio Implant 3.3 for Win 64-bit
• 07332747172805: DTX Studio Implant 3.5 for Windows 64-bit
• 07332747172829: DTX Studio Implant 3.5 for Mac
• 07332747181944: DTX Studio Implant 3.6 for Mac
• 07332747181937: DTX Studio Implant 3.6 for Windows 64-bit