FDA 510(k) Application Details - K240950

Device Classification Name	Handpiece, Contra- And Right-Angle Attachment, Dental   More FDA Info for this Device
510(K) Number	K240950
Device Name	Handpiece, Contra- And Right-Angle Attachment, Dental
Applicant	Pacific Care Limited Unit 308-309, 15W, Hong Kong Science Park N.T. HK Other 510(k) Applications for this Company
Contact	Chris Kwong Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EGS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/08/2024
Decision Date	05/28/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review