FDA 510(k) Application Details - K182313

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K182313
Device Name	Implant, Endosseous, Root-Form
Applicant	Medical Instinct Deutschland GmbH Graseweg 24 Bovenden 37120 DE Other 510(k) Applications for this Company
Contact	Jan Worlitz Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2018
Decision Date	03/11/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review