FDA 510(k) Application Details - K220771

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K220771
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	Stratasys Ltd 1 Holtzman St. Science Park P.O. Box 2496 Rehovot 7612401 IL Other 510(k) Applications for this Company
Contact	Melanie Glennon 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	03/16/2022
Decision Date	07/07/2022
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