FDA 510(k) Application Details - K222418

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K222418
Device Name	Aligner, Sequential
Applicant	Gruppo Europeo Ortodonzia srl via Cropani, 118 A/B Rome 00173 IT Other 510(k) Applications for this Company
Contact	Massimiliano Bucceri 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	08/10/2022
Decision Date	10/07/2022
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