FDA 510(k) Application Details - K233419

Device Classification Name	Screw, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K233419
Device Name	Screw, Fixation, Intraosseous
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	872.4880   More FDA Info for this Regulation Number
Classification Product Code	DZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/2023
Decision Date	01/03/2025
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