FDA 510(k) Application Details - K182388

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K182388
Device Name	Aligner, Sequential
Applicant	Shatkin F.I.R.S.T. LLC 2495 Kensington Avenue Amherst, NY 14226 US Other 510(k) Applications for this Company
Contact	Kimberly Wiesmore 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	09/04/2018
Decision Date	12/19/2019
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