FDA 510(k) Application Details - K193352

Device Classification Name	More FDA Info for this Device
510(K) Number	K193352
Device Name	AbutmentCAD
Applicant	exocad GmbH 37, Julius-Reiber-Str. Darmstadt 64293 DE Other 510(k) Applications for this Company
Contact	Stefan Walter Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2019
Decision Date	07/21/2021
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