FDA 510(k) Application Details - K182658

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K182658
Device Name	Aligner, Sequential
Applicant	Five Star Orthodontic Lab & Supply 2928 Metro Street, Suite 102 Denton, TX 76207 US Other 510(k) Applications for this Company
Contact	Andrew Loch Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	NXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2018
Decision Date	06/19/2019
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