FDA 510(k) Application Details - K233152

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K233152
Device Name	Aligner, Sequential
Applicant	Geniova Technologies Sociedad Limitada Calle Valentin Beato 21, planta-1 Madrid 28037 ES Other 510(k) Applications for this Company
Contact	Antonio Baselga de la Vega 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	09/27/2023
Decision Date	12/12/2024
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