FDA 510(k) Application Details - K193623

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K193623
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	DIO Corporation 66, Centum Seo-ro, Haeundae-gu Busan 48058 KR Other 510(k) Applications for this Company
Contact	Jiae Park Other 510(k) Applications for this Contact
Regulation Number	872.3760   More FDA Info for this Regulation Number
Classification Product Code	EBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2019
Decision Date	10/22/2020
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