FDA 510(k) Application Details - K212303

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K212303
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	Osstem Implant Co., Ltd. 2 Floor, B-dong, 51, Mayu-ro 238beon-gil Siheung-si 15079 KR Other 510(k) Applications for this Company
Contact	Jinwoo Bae 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	07/23/2021
Decision Date	09/21/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review