FDA 510(k) Application Details - K231100

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K231100
Device Name	Implant, Endosseous, Root-Form
Applicant	Proimtech Saglik Urunleri Anonim Sirketi Imes Sitesi, No:3 Dudullu Osb Mahallesi Imes 305.Sokak Istanbul 34773 TR Other 510(k) Applications for this Company
Contact	Hakan Cevik 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	04/18/2023
Decision Date	08/23/2024
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