FDA 510(k) Application Details - K233122

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K233122
Device Name	Handpiece, Air-Powered, Dental
Applicant	Litu Tech Ltd. C1-2 No. 12 Denengxi Road Torch Zone, Zhongshan Guangdong 528437 CN Other 510(k) Applications for this Company
Contact	Guangzhao Liu Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EFB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2023
Decision Date	04/30/2024
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