FDA 510(k) Application Details - K202674

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K202674
Device Name	Handpiece, Air-Powered, Dental
Applicant	Pac-Dent, Inc. 670 Endeavor Circle Brea, CA 92821 US Other 510(k) Applications for this Company
Contact	Jiahe Li 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	09/15/2020
Decision Date	12/12/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review