DTX Studio(tm) Implant 300843

GUDID 07332747166101

DTX Studio Implant 3.4 for Win 64-bit

Nobel Biocare AB

Dental treatment application software

• Primary Device ID: 07332747166101
• NIH Device Record Key: 2babc260-6c20-4e30-99c4-115ab62ebd98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DTX Studio(tm) Implant
• Version Model Number: 3.4
• 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: 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: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747166101 [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: 2019-05-06

On-Brand Devices [DTX Studio(tm) Implant]

• 07332747166125: DTX Studio Implant 3.4 for Mac
• 07332747166101: DTX Studio Implant 3.4 for Win 64-bit