FDA 510(k) Application Details - K182422

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K182422
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	Dentsply Sirona 221 West Philadelphia Street, Suite 60 York, PA 17404 US Other 510(k) Applications for this Company
Contact	Karl Nittinger Other 510(k) Applications for this Contact
Regulation Number	872.3760   More FDA Info for this Regulation Number
Classification Product Code	EBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/06/2018
Decision Date	12/18/2018
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