FDA 510(k) Application Details - K213477

Device Classification Name	Unit, Electrosurgical, And Accessories, Dental   More FDA Info for this Device
510(K) Number	K213477
Device Name	Unit, Electrosurgical, And Accessories, Dental
Applicant	J. Morita USA, Inc. 9 Mason Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Fujio Zushi Other 510(k) Applications for this Contact
Regulation Number	872.4920   More FDA Info for this Regulation Number
Classification Product Code	EKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/29/2021
Decision Date	08/03/2022
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	N
Expedited Review