FDA 510(k) Application Details - K242661

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K242661
Device Name	Implant, Endosseous, Root-Form
Applicant	TRI Dental Implants Int. AG Boesch 80A/Postfach 419 Huenenberg CH-6331 CH Other 510(k) Applications for this Company
Contact	Sandro Venanzoni 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	09/04/2024
Decision Date	01/08/2025
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