FDA 510(k) Application Details - K191838

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K191838
Device Name	Aligner, Sequential
Applicant	Motor City Lab Works 2200 Holland Street Birmingham, MI 48009 US Other 510(k) Applications for this Company
Contact	Christina Groth 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	07/09/2019
Decision Date	03/20/2020
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