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FDA 510(k)

DTX Studio Assist

K-Number: K252086 · 2025-11-17

ApplicantNobel Biocare C/O Medicim NV
Decision Date2025-11-17
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DTX Studio Assist is a medical device manufactured by Nobel Biocare C/O Medicim NV. It received FDA 510(k) clearance on 2025-11-17 under approval number K252086. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DTX Studio Assist?

DTX Studio Assist is a medical device that received FDA 510(k) clearance on 2025-11-17. It is manufactured by Nobel Biocare C/O Medicim NV. The 510(k) number is K252086.

When was DTX Studio Assist approved by the FDA?

DTX Studio Assist received FDA 510(k) clearance on 2025-11-17, under approval number K252086.

What company makes DTX Studio Assist?

DTX Studio Assist is manufactured by Nobel Biocare C/O Medicim NV.

What is the FDA product code for DTX Studio Assist?

The FDA product code for DTX Studio Assist is MYN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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