FDA 510(k) Application Details - K233502

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K233502
Device Name	Material, Tooth Shade, Resin
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	872.3690   More FDA Info for this Regulation Number
Classification Product Code	EBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2023
Decision Date	11/01/2023
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	Y
Expedited Review