FDA 510(k) Application Details - K211871

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K211871
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	Faico Medical LLC 2424 North Federal Highway, Suite 103 Boca Raton, FL 33428 US Other 510(k) Applications for this Company
Contact	Hernan Dario Fernandez 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	06/17/2021
Decision Date	11/18/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review