FDA 510(k) Application Details - K242317

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K242317
Device Name	Scaler, Ultrasonic
Applicant	Denjoy Dental Co., Ltd. F4, Building A4, Lugu Medical Device Park, No.229 Guyuan Road Changsha 410205 CN Other 510(k) Applications for this Company
Contact	Chengfa Huang Other 510(k) Applications for this Contact
Regulation Number	872.4850   More FDA Info for this Regulation Number
Classification Product Code	ELC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2024
Decision Date	02/13/2025
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