FDA 510(k) Application Details - K250473

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K250473
Device Name	Unit, Operative Dental
Applicant	DCI International LLC 705 S Springbrook Road Bldg. C Newberg, OR 97132 US Other 510(k) Applications for this Company
Contact	Dana Shusterman Other 510(k) Applications for this Contact
Regulation Number	872.6640   More FDA Info for this Regulation Number
Classification Product Code	EIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2025
Decision Date	02/19/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review