FDA 510(k) Application Details - K231181

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K231181
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	Dentium Co., Ltd (ICT Branch) 76, Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si 16229 KR Other 510(k) Applications for this Company
Contact	Sang Woo Lee Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	OAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2023
Decision Date	12/14/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review