FDA 510(k) Application Details - K200100

Device Classification Name	More FDA Info for this Device
510(K) Number	K200100
Device Name	Abutment Design
Applicant	3Shape A/S Holmens Kanal 7 Copenhagen 1060 DK Other 510(k) Applications for this Company
Contact	Jenny Axel 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	01/16/2020
Decision Date	10/07/2020
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