FDA 510(k) Application Details - K201317

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K201317
Device Name	Scaler, Ultrasonic
Applicant	TTBIO CORP. 2F, NO.7, 6TH Road Industry Park Taichung 40755 TW Other 510(k) Applications for this Company
Contact	Sheng-Chieh Su 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	05/18/2020
Decision Date	12/04/2020
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