DTX Studio™ Assist

Basic Information

• Brand Name: DTX Studio™ Assist
• Primary DI: 07332747221862
• Version / Model: 1.1
• Catalog Number: 302261
• Company Name: Nobel Biocare AB
• Labeler DUNS: 353939929
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-01
• Public Version: 1
• Public Version Date: 2025-12-09
• Public Version Status: New
• Public Device Record Key: f1a69471-892b-48b2-8029-2fc534eb00f3

Device Description

DTX Studio Assist 1.1 for Mac

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MYN	Analyzer, medical image	Radiology	892.2070	2
QIH	Automated Radiological Image Processing Software	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65472	Dental x-ray image interpretive software	An interpretive software program intended to be used to analyse dental x-ray images (e.g., panoramic and bitewing) to facilitate the localization and classification of teeth, detect abnormalities (e.g., caries, apical lesion), and identify past dental procedures (e.g., fillings, crowns, bridges, implants); it utilizes artificial intelligence (AI)/deep learning algorithms.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07332747221862	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K252086	000