FDA 510(k) Application Details - K201334

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K201334
Device Name	Implant, Endosseous, Root-Form
Applicant	Keystone Dental Inc. 154 Middlesex Turnpike Burlington, MA 01803 US Other 510(k) Applications for this Company
Contact	Linda Jalbert 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	05/20/2020
Decision Date	08/18/2020
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