FDA 510(k) Application Details - K230410

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K230410
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	Dental Direkt GmbH Industriezentrum 106-108 Spenge 32139 DE Other 510(k) Applications for this Company
Contact	Patrick Berz 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	02/15/2023
Decision Date	06/23/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review