K-number	K252086
Device name	DTX Studio Assist
Applicant	Nobel Biocare C/O Medicim NV
Product code	MYN
Device class	Class II
Decision date	Nov 17, 2025
Decision	Substantially Equivalent
Regulation	892.2070

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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DTX Studio Assist

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