FDA 510(k) Application Details - K211872

Device Classification Name	Blade-Form Endosseous Dental Implant   More FDA Info for this Device
510(K) Number	K211872
Device Name	Blade-Form Endosseous Dental Implant
Applicant	Rex Implants, Inc. 850 Michigan Avenue Columbus, OH 43215 US Other 510(k) Applications for this Company
Contact	Giuseppe Vercellotti Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	NRQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2021
Decision Date	10/12/2022
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