FDA 510(k)

DTX Studio Assist

K-Number: K252086 · 2025-11-17

Decision Date2025-11-17

Product CodeMYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DTX Studio Assist is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare C/O Medicim NV. It received FDA 510(k) clearance on 2025-11-17 under 510(k) 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. The listed applicant is Nobel Biocare C/O Medicim NV. The 510(k) number is K252086.

When did DTX Studio Assist receive FDA 510(k) clearance?

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

Who is the listed applicant for DTX Studio Assist?

The FDA 510(k) record lists Nobel Biocare C/O Medicim NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DTX Studio Assist?

The FDA product code for DTX Studio Assist is MYN.

Related Devices (Code: MYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261059Overjet Multi-Image Caries and Charting AssistOverjet, Inc.K260851Better Diagnostics Dental Assist (BDDA) Version 1.0Better Diagnostics AI Corp.K252953Velmeni for Dentists (V4D) Endo-PerioVelmeni, Inc.K251934qXR-DetectQure.Ai Technologies K252934DiagnocatDGNCT, LLC K253009DS Core DetectDentsply Sirona, Inc.

Official Source

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