K232393

BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge

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. CO · US
Product code
QYJ — Dental Waterline Treatment Cartridge
Decision date
2023-10-27
Date received
2023-08-09
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K232393.pdf

Official FDA record: K232393
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.