FDA 510(k) Application Details - K232076

Device Classification Name	More FDA Info for this Device
510(K) Number	K232076
Device Name	Fibercure
Applicant	Lumendo AG Chemin du Closel 5 Renens 1020 CH Other 510(k) Applications for this Company
Contact	Mark Bispinghoff Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/2023
Decision Date	11/02/2023
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