FDA 510(k) Application Details - K203442

Device Classification Name	More FDA Info for this Device
510(K) Number	K203442
Device Name	Inbrace Orthodontic System
Applicant	Swift Health Systems, Inc. 111 Academy, Suite 150 Irvine, CA 92617 US Other 510(k) Applications for this Company
Contact	Alicia Mszyca 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	11/23/2020
Decision Date	02/19/2021
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