RAYDENT SW
RAY Co., Ltd.RAYDENT SW is software that helps dental professionals plan treatments and design orthodontic and prosthetic devices by using 3D imaging data and simulations. It assists in creating treatment plans and designing devices such as clear aligners, crowns, veneers, and bridges, improving precision and efficiency in dental care.
Intended Use
Software designed to assist dental professionals in planning patient treatment and designing treatment devices including prosthetic and orthodontic devices based on 3D mesh data and simulations.
Technology
Software operates by acquiring patient images from compatible scanners, creating 3D virtual dental models, simulating orthodontic treatments, and designing virtual orthodontic appliances and prostheses like crowns and bridges. It supports various dental 2D/3D image formats and requires user expertise and training.
Performance
The software underwent verification and validation testing per FDA guidance on device software functions and cybersecurity; all tests were reviewed and approved showing substantial equivalence to predicate devices. Clinical testing was not required or performed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/13/2023
6 months - 2
FDA Approval
5/16/2024
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