FDA 510(k) Application Details - K211721

Device Classification Name	Handpiece, Air-Powered, Root Canal Irrigation   More FDA Info for this Device
510(K) Number	K211721
Device Name	Handpiece, Air-Powered, Root Canal Irrigation
Applicant	Inter-Med, INC. 2200 South Street Racine, WI 53404 US Other 510(k) Applications for this Company
Contact	Brett Arand Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	NYL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/2021
Decision Date	12/02/2021
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