FDA 510(k) Application Details - K212770

Device Classification Name	More FDA Info for this Device
510(K) Number	K212770
Device Name	Vision
Applicant	SoftSmile, Inc. 16192 Coastal Highway Lewes, DE 19958 US Other 510(k) Applications for this Company
Contact	Khamzat Asabaev Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/31/2021
Decision Date	12/21/2021
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