FDA 510(k) Application Details - K250015

Device Classification Name	Adhesive, Bracket And Tooth Conditioner, Resin   More FDA Info for this Device
510(K) Number	K250015
Device Name	Adhesive, Bracket And Tooth Conditioner, Resin
Applicant	Ormco Corporation 200 S Kraemer Blvd Brea, CA 92821 US Other 510(k) Applications for this Company
Contact	Tara Bonny Other 510(k) Applications for this Contact
Regulation Number	872.3750   More FDA Info for this Regulation Number
Classification Product Code	DYH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2025
Decision Date	01/03/2025
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	Y
Expedited Review