FDA 510(k) Application Details - K182338

Device Classification Name	Bracket, Plastic, Orthodontic   More FDA Info for this Device
510(K) Number	K182338
Device Name	Bracket, Plastic, Orthodontic
Applicant	Blue Sky Bio 888 E Belvedere Rd Suite 212 Grayslake, IL 60030 US Other 510(k) Applications for this Company
Contact	Albert Zickmann 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	08/28/2018
Decision Date	11/09/2018
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