FDA 510(k) Application Details - K243777

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K243777
Device Name	Varnish, Cavity
Applicant	Theodent, LLC 1441 Canal Street New Orleans, LA 70112 US Other 510(k) Applications for this Company
Contact	Joseph Fuselier Other 510(k) Applications for this Contact
Regulation Number	872.3260   More FDA Info for this Regulation Number
Classification Product Code	LBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2024
Decision Date	05/27/2025
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