FDA 510(k) Application Details - K242611

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K242611
Device Name	Unit, Operative Dental
Applicant	Mipont Medical Equipment Co., Ltd. No.101, No.201, No.203, Building 1, Guangming Technology Pk Lanhe Avenue, Lanhe, Nansha Guangzhou 511480 CN Other 510(k) Applications for this Company
Contact	Chen Salon 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	09/03/2024
Decision Date	05/27/2025
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