FDA 510(k) Application Details - K213749

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K213749
Device Name	Unit, Operative Dental
Applicant	Shinhung Company Ltd Shinhung Bldg, 450 Cheongpa-ro, Jung-gu Seoul 100-858 KR Other 510(k) Applications for this Company
Contact	Sam Su Kyong Other 510(k) Applications for this Contact
Regulation Number	872.6640   More FDA Info for this Regulation Number
Classification Product Code	EIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2021
Decision Date	04/03/2023
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	N
Expedited Review