FDA 510(k) Application Details - K241153

Device Classification Name	More FDA Info for this Device
510(K) Number	K241153
Device Name	Progressive Orthodontics App
Applicant	Progressive Aligners Inc. 135 Columbia Aliso Viejo, CA 92656 US Other 510(k) Applications for this Company
Contact	Fouad Alaeddin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2024
Decision Date	10/11/2024
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