FDA 510(k) Application Details - K191591

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K191591
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	Enlighten Materials Co., Ltd 8F., NO.138, Sec.2, Jinshan S. Rd., Da-an Dist Taipei 10642 TW Other 510(k) Applications for this Company
Contact	Jiun Ming Su 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	06/14/2019
Decision Date	08/18/2020
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