FDA 510(k) Application Details - K250778

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K250778
Device Name	Material, Tooth Shade, Resin
Applicant	DSI Dental Solutions Ltd 59 ha Avoda St Light Industrial Zone Ashdod 7706300 IL Other 510(k) Applications for this Company
Contact	Shlomi Krasner Other 510(k) Applications for this Contact
Regulation Number	872.3690   More FDA Info for this Regulation Number
Classification Product Code	EBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/2025
Decision Date	05/23/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review