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--- en:bitesplint_3d [2024/02/12 20:21] – [Module Bite Splint 3D] onyxadmin
+++ en:bitesplint_3d [2024/03/02 15:15] (current) – [Module Bite Splint 3D] onyxadmin
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 The module Bite Splint can be used to design one splint with the impression of the opposing jaw, two splints interacting with each other, or a combined splint for both jaws. Useful combination of tray, free-form 3D components and parts from the user-maintained 3D object library allow flexible design.\\
-The Bite Splint module provides software tools for designing virtual splints based on image or scan data. In doing so, the user must ensure the suitability of the output data and the manipulations and calculations performed on it for the intended use in the context of the intended treatment measures. According to the intended purpose, clinical decisions must not be based exclusively or even primarily on the results provided by the software.\\
+The Bite Splint module provides software tools for designing virtual splints based on image or scan data. In doing so, the user must ensure the suitability of the output data and the manipulations and calculations performed on it for the intended use in the context of the intended treatment measures. According to the intended purpose, clinical decisions cannot be motivated exclusively or even mainly on evaluation results provided by the software. The classification as a medical device cannot be transferred to treatment measures or the manufacture of orthodontic appliances, even if these take into account the calculation results of the software.\\
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