FDA 510(k) Application Details - K202685

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K202685
Device Name	Aligner, Sequential
Applicant	Eon Dental Jordan LLC 385 King Abdullah II Street Amman 11810 JO Other 510(k) Applications for this Company
Contact	Fadi Samawi 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	09/15/2020
Decision Date	09/28/2020
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	Y
Expedited Review