FDA 510(k) Application Details - K240597

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K240597
Device Name	Aligner, Sequential
Applicant	Graphy Inc. 603, #617, Ace Gasan Forhu, 225, Gasan digital 1-ro, Geumcheon-gu, Seoul 08501 KR Other 510(k) Applications for this Company
Contact	Moon-Soo Park 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	03/04/2024
Decision Date	03/05/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	Y
Expedited Review