510(k) Report

FDA applicant

Proedge Dental Products, Inc.

Centennial, CO1 decision2023–20230 recalls

FDA records 1 decision for Proedge Dental Products, Inc. (Centennial, CO) in 2023: 1 510(k) clearance. All are in product code QYJ (Dental Waterline Treatment Cartridge). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Proedge Dental Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Proedge Dental Products, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Proedge Dental Products, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • QYJDental Waterline Treatment Cartridge1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K232393BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline…Proedge Dental Products, Inc. · 2023

The one decision as Proedge Dental Products, Inc. →