FDA 510(k) Application Details - K251297

Device Classification Name	More FDA Info for this Device
510(K) Number	K251297
Device Name	MIS LYNX Conical Connection Implant System
Applicant	Dentsply Sirona Inc. 221 West Philadelphia St., Suite 60W York, PA 17401 US Other 510(k) Applications for this Company
Contact	Jesus Valencia Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2025
Decision Date	07/24/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review