DTX Studio Clinic (4.0)
Nobel Biocare ABDTX Studio Clinic (4.0) is a dental and craniomaxillofacial imaging software that assists clinicians by analyzing 2D intraoral radiographs with AI to detect dental issues such as caries, calculus, and bone loss. It supports diagnostic workflows and treatment planning, including guided implant surgery, by managing and enhancing images from various sources and facilitating image sharing and review.
Intended Use
DTX Studio Clinic is a software program for acquisition, management, transfer, and analysis of dental and craniomaxillofacial image information, to support diagnostic process and treatment planning including design input for dental restorative solutions, and to aid guided implant surgery.
Technology
The device incorporates an AI-powered Focus Area Detection algorithm based on supervised machine learning to analyze 2D intraoral radiographs for dental findings. It supports image import from multiple sources, 2D and 3D image review, applies filters, measures anatomy, and exports data. It also creates digital surgical template files (.stl) from implant plans.
Performance
Software verification and validation were performed following FDA guidance with moderate level of concern, including comparative analysis of AI detection output against predicate devices, showing equivalent focus area detection performance and correctness of digital surgical template file creation.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/28/2023
5 months - 2
FDA Approval
12/8/2023
Other devices from Nobel Biocare AB
- DTX Studio Clinic 3.02023 • 510K
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