FDA 510(k) Application Details - K231039

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K231039
Device Name	Agent, Tooth Bonding, Resin
Applicant	Kuraray Noritake Dental Inc. Tokiwabashi Tower, 2-6-4, Otemachi Chiyoda-ku 100-0004 JP Other 510(k) Applications for this Company
Contact	Yasujiro Ohara 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	04/12/2023
Decision Date	12/13/2023
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