FDA 510(k) Application Details - K231817

Device Classification Name	Adhesive, Bracket And Tooth Conditioner, Resin   More FDA Info for this Device
510(K) Number	K231817
Device Name	Adhesive, Bracket And Tooth Conditioner, Resin
Applicant	VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven 27472 DE Other 510(k) Applications for this Company
Contact	Verena Kollek 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	06/21/2023
Decision Date	12/01/2023
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	N
Expedited Review