FDA 510(k) Application Details - K193139

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K193139
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	Durr Dental SE Hopfigheimer Str. 17 Bietigheim-Bissingen 74321 DE Other 510(k) Applications for this Company
Contact	Oliver Lange 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	11/13/2019
Decision Date	03/05/2020
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