FDA 510(k) Application Details - K180404

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K180404
Device Name	Bracket, Ceramic, Orthodontic
Applicant	3M Health Care 2510 Conway Avenue St. Paul, MN 55144-1000 US Other 510(k) Applications for this Company
Contact	Lam Duong Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	NJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2018
Decision Date	03/16/2018
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