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510(k) K232393

BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge by Proedge Dental Products, Inc. — Product Code QYJ

K232393 is an FDA 510(k) premarket notification submitted by Proedge Dental Products, Inc. for the device "BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge". The FDA issued a decision of Substantially Equivalent on October 27, 2023. The device falls under product code QYJ (Dental Waterline Treatment Cartridge), a Class I device regulated under 21 CFR 872.6640.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2023
Date Received
August 9, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dental Waterline Treatment Cartridge
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

Intended to reduce microbial bioburden in dental unit water lines

FDA data resources