Home / 510(k) Clearances / K252086

510(k) K252086

DTX Studio Assist by Nobel Biocare C/O Medicim NV — Product Code MYN

K252086 is an FDA 510(k) premarket notification submitted by Nobel Biocare C/O Medicim NV for the device "DTX Studio Assist". The FDA issued a decision of Substantially Equivalent on November 17, 2025. The device falls under product code MYN (Analyzer, Medical Image), a Class II device regulated under 21 CFR 892.2070.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2025
Date Received
July 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Medical Image
Device Class
Class II
Regulation Number
892.2070
Review Panel
RA
Submission Type

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 clearances for product code MYN

  • K260851 — Better Diagnostics Dental Assist (BDDA) Version 1.0 (July 15, 2026)
  • K252953 — Velmeni for Dentists (V4D) Endo-Perio (May 11, 2026)
  • K251934 — qXR-Detect (January 16, 2026)
  • K252934 — Diagnocat (January 15, 2026)
  • K253009 — DS Core Detect (January 7, 2026)
  • K250525 — Second Opinion® Panoramic (November 14, 2025)
  • K250264 — SugarBug (1.x) (November 7, 2025)
  • K251002 — Videa Dental AI (September 19, 2025)
  • K250753 — VELMENI for DENTISTS (V4D) (September 2, 2025)
  • K243234 — Second Opinion® CS (June 12, 2025)

FDA data resources