FDA 510(k) Application Details - K201940

Device Classification Name	Bracket, Plastic, Orthodontic   More FDA Info for this Device
510(K) Number	K201940
Device Name	Bracket, Plastic, Orthodontic
Applicant	Braces on Demand, Inc 422 South Broadway, Suite 223 Hicksville, NY 11801 US Other 510(k) Applications for this Company
Contact	Colin Corey Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	DYW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/2020
Decision Date	12/03/2020
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	N
Expedited Review