FDA 510(k) Application Details - K202369

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K202369
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	Rolence Enterprise Inc. 18-3 Lane 231 Pu Chung Rd., Chungli Taoyuan 32083 TW Other 510(k) Applications for this Company
Contact	Ben Chang Other 510(k) Applications for this Contact
Regulation Number	872.1800   More FDA Info for this Regulation Number
Classification Product Code	MUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/2020
Decision Date	09/15/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review