FDA 510(k) Application Details - K250969

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K250969
Device Name	Material, Impression
Applicant	Dent4You AG Bahnhofstrasse 2 Heerbrugg 9435 CH Other 510(k) Applications for this Company
Contact	Oliver Ashe Other 510(k) Applications for this Contact
Regulation Number	872.3660   More FDA Info for this Regulation Number
Classification Product Code	ELW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2025
Decision Date	06/27/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review