FDA 510(k) Application Details - K250872

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K250872
Device Name	Implant, Endosseous, Root-Form
Applicant	Bioline Dental Implant Systems Ltd 1 Haella St Tefen Industrial Park POB 70 Migdal Tefen 2495900 IL Other 510(k) Applications for this Company
Contact	Asher Ohayon 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	03/24/2025
Decision Date	06/18/2025
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