FDA 510(k) Application Details - K212664

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K212664
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	Open Implants, LLC 800 West Cummngs Ave, Suite 4900 Woburn, MA 01801 US Other 510(k) Applications for this Company
Contact	Gregg Gellman Other 510(k) Applications for this Contact
Regulation Number	872.3630   More FDA Info for this Regulation Number
Classification Product Code	NHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2021
Decision Date	11/30/2021
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