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BluTube® Dental Unit Water Purification Cartridge (BluTube®) +1 more model

FDA 510(k)

Class I (US FDA 510(k))

510(k) K232393

by Proedge Dental Products, Inc.

Identifiers

510(k) Number
K232393 FDA 510(k)
FDA Product Code
QYJ FDA 510(k)
Models / Variants
BluTube® Dental Unit Water Purification Cartridge (BluTube®) FDA 510(k)
Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge FDA 510(k)

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 872.6640 FDA 510(k)
Regulation Number
872.6640 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

BluTube® Dental Unit Water Purification Cartridge (BluTube®) +1 more model by Proedge Dental Products, Inc. — Class I — FDA_510K — listed in FDA 510(k) — 2…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Proedge Dental Products, Inc.

Sources (1)

  • FDA 510(k) K232393 24 fields · synced Jun 19, 2026