FDA 510(k) Application Details - K241462

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K241462
Device Name	Implant, Endosseous, Root-Form
Applicant	Noris Medical Ltd. 8 Hataasia St. Nesher 3688808 IL Other 510(k) Applications for this Company
Contact	Noa Mor Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2024
Decision Date	02/11/2025
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