510(k) Report

FDA applicant

Allodex Systems

Scottsdale, AZ1 decision2002–20020 recalls

FDA records 1 decision for Allodex Systems (Scottsdale, AZ) in 2002: 1 510(k) clearance. All are in product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin). Its devices cite 1 predicate, 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 Allodex Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Allodex Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Allodex Systems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Allodex Systems’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?

  • DYHAdhesive, Bracket And Tooth Conditioner, Resin1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K020648Gridlock 195 AdhesiveAllodex Systems · 2002

The one decision as Allodex Systems →