FDA 510(k) Application Details - K233995

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K233995
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	Ivoclar Vivadent, Inc 175 Pineview Drive Amherst, NY 14228 US Other 510(k) Applications for this Company
Contact	Anderjeet Gulati 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	12/18/2023
Decision Date	02/23/2024
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