BluTube® Dental Unit Water Purification Cartridge (BluTube®) +1 more— 510(k) K232393

Name: FDA 510(k) clearance K232393
Creator: U.S. Food and Drug Administration
Published: 2023-10-27

Substantially Equivalent

Proedge Dental Products, Inc.

FDA 510(k) clearance K232393 for BluTube® Dental Unit Water Purification Cartridge (BluTube®) +1 more, Substantially Equivalent on 2023-10-27. Applicant: Proedge Dental Products, Inc.. Device class: 1.

Clearance details

Device name as filed: 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.
Product code: Code QYJ
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2023-08-09
Decision date: 2023-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Centennial, CO, US

Download summary PDF View on FDA.gov ↗

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