FDA 510(k) Application Details - K183424

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K183424
Device Name	Agent, Tooth Bonding, Resin
Applicant	DentsCare LTDA Av. Edgar Nilson Meister, 474 Joinville 89219-501 BR Other 510(k) Applications for this Company
Contact	Roberta Uyara Other 510(k) Applications for this Contact
Regulation Number	872.3200   More FDA Info for this Regulation Number
Classification Product Code	KLE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2018
Decision Date	12/13/2019
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