FDA 510(k) Application Details - K210228

Device Classification Name	Implant, Subperiosteal   More FDA Info for this Device
510(K) Number	K210228
Device Name	Implant, Subperiosteal
Applicant	KLS-Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville, FL 32246 US Other 510(k) Applications for this Company
Contact	Jennifer Damato Other 510(k) Applications for this Contact
Regulation Number	872.3645   More FDA Info for this Regulation Number
Classification Product Code	ELE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/28/2021
Decision Date	07/08/2022
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