DTX Studio Assist

FDA 510(k) K252086 · Nobel Biocare C/O Medicim NV

Substantially Equivalent

510(k) numberK252086

Submission

Device name
DTX Studio Assist
Applicant
Nobel Biocare C/O Medicim NV
Mechelen, BE
Received
July 2, 2025
Decision date
November 17, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MYN – Analyzer, Medical Image
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2070
Specialty
Radiology

For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers

Other 510(k)s with product code MYN

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K252486ChestView US (1.1)MYN · Traditional Gleamer09/09/2026SE
K261059Overjet Multi-Image Caries and Charting AssistMYN · Traditional Overjet, Inc.08/06/2026SE
K260851Better Diagnostics Dental Assist (BDDA) Version 1.0MYN · Traditional Better Diagnostics AI Corp.07/15/2026SE
K252953Velmeni for Dentists (V4D) Endo-PerioMYN · Traditional Velmeni, Inc.05/11/2026SE
K251934qXR-DetectMYN · Traditional Qure.Ai Technologies01/16/2026SE
K252934DiagnocatMYN · Traditional Dgnct, LLC01/15/2026SE
K253009DS Core DetectMYN · Traditional Dentsply Sirona, Inc.01/07/2026SE
K250525Second Opinion® PanoramicMYN · Traditional Pearl, Inc.11/14/2025SE
K250264SugarBug (1.x)MYN · Traditional Bench7, Inc.11/07/2025SE
K251002Videa Dental AIMYN · Traditional Videahealth, Inc.09/19/2025SE

Questions and answers

When was DTX Studio Assist cleared by the FDA?

DTX Studio Assist (K252086) received a 510(k) decision of Substantially Equivalent on November 17, 2025, 138 days after the submission was received.

What is the product code of K252086?

The FDA product code is MYN – Analyzer, Medical Image, a Class II (moderate risk) device regulated under 21 CFR 892.2070.