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FDA 510(k)

BluTube®牙科单元水净化滤芯（BluTube®）；型号：WB180，WB90，Z3水线净化吸管，牙科单元水净化滤芯

K号: K232393 · 2023-10-27

申请人Proedge Dental Products, Inc.
决定日期2023-10-27
产品代码QYJ
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决定实质等同

器械摘要

BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Proedge Dental Products, Inc.. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K232393. The device is classified under product code QYJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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

BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Proedge Dental Products, Inc.. The 510(k) number is K232393.

When did BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge receive FDA 510(k) clearance?

BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge received FDA 510(k) clearance on 2023-10-27, under 510(k) number K232393.

Who is the listed applicant for BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge?

The FDA 510(k) record lists Proedge Dental Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge?

The FDA product code for BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge is QYJ.

相关临床试验

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NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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