Cleared Traditional

K232393 - BluTube® Dental Unit Water Purification Cartridge (BluTube®) (FDA 510(k) Clearance)

Also includes:
Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge

Class I Dental device.

K232393 · Proedge Dental Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
79d
Days
Class 1
Risk

K232393 is an FDA 510(k) clearance for the BluTube® Dental Unit Water Purification Cartridge (BluTube®). Classified as Dental Waterline Treatment Cartridge (product code QYJ), Class I - General Controls.

Submitted by Proedge Dental Products, Inc. (Centennial, US). The FDA issued a Cleared decision on October 27, 2023 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Proedge Dental Products, Inc. devices

Submission Details

510(k) Number K232393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2023
Decision Date October 27, 2023
Days to Decision 79 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 127d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QYJ Dental Waterline Treatment Cartridge
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
Definition Intended To Reduce Microbial Bioburden In Dental Unit Water Lines
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Exponent, Inc.
Ian Van Trump

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.