FDA 510(k) Application Details - K231297

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K231297
Device Name	Unit, Operative Dental
Applicant	Firstar Dental Company 18915 East Valley Highway Kent, WA 98032 US Other 510(k) Applications for this Company
Contact	Kang N Lei Other 510(k) Applications for this Contact
Regulation Number	872.6640   More FDA Info for this Regulation Number
Classification Product Code	EIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2023
Decision Date	01/27/2025
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