FDA 510(k) Application Details - K250606

Device Classification Name	More FDA Info for this Device
510(K) Number	K250606
Device Name	Dental Barrier and Sleeves
Applicant	Yueying Medical Instruments (Langfang) Co., Ltd. Dong Xiangzhuang Village, Hou Yi Town, Yongqing County Langfang CN Other 510(k) Applications for this Company
Contact	Xiaoliang Wang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2025
Decision Date	05/29/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review