FDA 510(k) Application Details - K201140

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K201140
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	Dentsply Sirona 221 West Philadelphia Street, Suite 60W York, PA 17401 US Other 510(k) Applications for this Company
Contact	Karl J. Nittinger Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	OAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/29/2020
Decision Date	06/22/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review