FDA 510(k) Application Details - K250295

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K250295
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 US Other 510(k) Applications for this Company
Contact	Laura Sobrin Other 510(k) Applications for this Contact
Regulation Number	872.3630   More FDA Info for this Regulation Number
Classification Product Code	NHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2025
Decision Date	04/30/2025
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