DTX Studio Assist— 510(k) K252086

Substantially Equivalent

Nobel Biocare C/O Medicim NV

FDA 510(k) clearance K252086 for DTX Studio Assist, Substantially Equivalent on 2025-11-17. Applicant: Nobel Biocare C/O Medicim NV.

Clearance details

Applicant: Nobel Biocare C/O Medicim NV
Product code: Code MYN
Advisory panel: Radiology
Date received: 2025-07-02
Decision date: 2025-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mechelen, BE

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.