FDA 510(k) Application Details - K243130

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K243130
Device Name	Unit, Operative Dental
Applicant	GUANGDONG YADENG MEDICAL APPARATUS CO., LTD., Factory 2, No.12, Fenggong Road, Nansha Industrial Zone, Danzao Town, Nanhai District Foshan 528216 CN Other 510(k) Applications for this Company
Contact	Chang Ming Weng 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	09/30/2024
Decision Date	06/27/2025
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