FDA 510(k) Application Details - K193408

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K193408
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	Dentsply Sirona 221 West Philadelphia St., Suite 60W York, PA 17401 US Other 510(k) Applications for this Company
Contact	Karl Nittinger 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	12/09/2019
Decision Date	08/16/2020
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