FDA 510(k) Application Details - K202965

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K202965
Device Name	Crown And Bridge, Temporary, Resin
Applicant	Mgnewton LTD. 472, Hanjanggun-ro, Jain-myeon Gyeongsan-si 38552 KR Other 510(k) Applications for this Company
Contact	Byoung Wook Ahn Other 510(k) Applications for this Contact
Regulation Number	872.3770   More FDA Info for this Regulation Number
Classification Product Code	EBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2020
Decision Date	12/21/2022
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