FDA 510(k) Application Details - K234043

Device Classification Name	Adhesive, Bracket And Tooth Conditioner, Resin   More FDA Info for this Device
510(K) Number	K234043
Device Name	Adhesive, Bracket And Tooth Conditioner, Resin
Applicant	3M Unitek Orthodontic Products 2724 South Peck Rd. Monrovia, CA 91016 US Other 510(k) Applications for this Company
Contact	Chandrapaul Parsram 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	12/21/2023
Decision Date	12/22/2023
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