FDA 510(k) Application Details - K152779

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K152779
Device Name	Bracket, Ceramic, Orthodontic
Applicant	Opal Orthodontics by Ultradent Products 505 West 10200 South South Jordan, UT 84095 US Other 510(k) Applications for this Company
Contact	Marie Hess 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	09/25/2015
Decision Date	11/25/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review