FDA 510(k) Application Details - K242715

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K242715
Device Name	Aligner, Sequential
Applicant	Pearl Digital Inc. 2975 Scott Blvd., Ste 110 Santa Clara, CA 95054 US Other 510(k) Applications for this Company
Contact	Henry Cao 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	09/10/2024
Decision Date	01/16/2025
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