FDA 510(k) Application Details - K212660

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K212660
Device Name	Aligner, Sequential
Applicant	Smylio, Inc 48890 Milmont Dr. Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Ren Menon 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	08/23/2021
Decision Date	09/22/2021
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