FDA 510(k) Application Details - K232393

Device Classification Name	More FDA Info for this Device
510(K) Number	K232393
Device Name	BluTube« Dental Unit Water Purification Cartridge (BluTube«); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge
Applicant	ProEdge Dental Products, Inc. 7042 South Revere Parkway, Suite 400 Centennial, CO 80112 US Other 510(k) Applications for this Company
Contact	Mark Frampton Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2023
Decision Date	10/27/2023
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