FDA 510(k) Application Details - K232243

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K232243
Device Name	Handpiece, Air-Powered, Dental
Applicant	Ttbio Corp. 2F., No.7, 6th Road Industry Park Taichung 40755 CN Other 510(k) Applications for this Company
Contact	Sheng-Chieh Su 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	07/28/2023
Decision Date	08/23/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review