510(k) Report

FDA applicant

Opal Orthodontics by Ultradent Products

South Jordan, UT2 decisions2012–20150 recalls

FDA records 2 decisions for Opal Orthodontics by Ultradent Products (South Jordan, UT) from 2012 to 2015: 2 510(k) clearances. All are in product code NJM (Bracket, Ceramic, Orthodontic). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Opal Orthodontics by Ultradent Products, Inc.”.

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 Opal Orthodontics by Ultradent Products’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2012: 12015: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Opal Orthodontics by Ultradent Products by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NJMBracket, Ceramic, Orthodontic2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K113334Avex CX2 and Avex CXI2 Ceramic BracketsOpal Orthodontics by Ultradent Products, Inc. · 20121cites it

What has FDA decided for it lately?

  • K152779Avex CX2Opal Orthodontics by Ultradent Products · 2015
  • K113334Avex CX2 and Avex CXI2 Ceramic BracketsOpal Orthodontics by Ultradent Products, Inc. · 2012

The one decision as Opal Orthodontics by Ultradent Products →The one decision as Opal Orthodontics by Ultradent Products, Inc. →