FDA 510(k) Application Details - K233868

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K233868
Device Name	Crown And Bridge, Temporary, Resin
Applicant	Kulzer, LLC 4315 S. Lafayette Blvd South Bend, IN 46614 US Other 510(k) Applications for this Company
Contact	David Vincent Other 510(k) Applications for this Contact
Regulation Number	872.3770   More FDA Info for this Regulation Number
Classification Product Code	EBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2023
Decision Date	05/23/2024
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