FDA 510(k) Application Details - K240754

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K240754
Device Name	Unit, Operative Dental
Applicant	MegaGen Implant Co., Ltd. 45, Secheon-ro Daegu 42921 KR Other 510(k) Applications for this Company
Contact	Lee Hyo-Eun 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	03/20/2024
Decision Date	03/21/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	Y
Expedited Review