FDA 510(k) Application Details - K210652

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K210652
Device Name	Aligner, Sequential
Applicant	SMS OPCO, LLC 672 Morning Star Drive, Suite 120 The Colony, TX 75056 US Other 510(k) Applications for this Company
Contact	Bruce Page 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	03/04/2021
Decision Date	06/02/2021
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