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510(k) · K252086

DTX Studio Assist

Nobel Biocare C/O Medicim NV
Radiology Class II RA
Clearance Date
November 17, 2025
Product Code
MYN
Device Class
Class II
Review Track
RA
PCCP
No
Submission Type
510(k)
Predicate Devices (3)
K231898 DTX Studio Clinic (4.0) Nobel Biocare AB · 2023 Primary
K221921 DTX Studio Clinic 3.0 Nobel Biocare AB · 2023
K242437 Smile Dx® Cube Click, Inc. · 2025
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