FDA 510(k) Application Details - K183138

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K183138
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	Biomet 3i 4555 Riverside Drive, Palm Beach Gardens, FL 33410 US Other 510(k) Applications for this Company
Contact	Krupal Patel 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	11/13/2018
Decision Date	07/02/2019
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