FDA 510(k) Application Details - K192913

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K192913
Device Name	Agent, Tooth Bonding, Resin
Applicant	Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. Fetih Mahallesi Mahir Sokak No:5/201 Konya 42030 TR Other 510(k) Applications for this Company
Contact	Muhammed Hulusi Sonmez 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	10/15/2019
Decision Date	01/19/2021
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