510(k) Report

FDA applicant

American Orthodontics

Sheboygan, WI46 decisions1989–20260 recalls

FDA records 46 decisions for American Orthodontics (Sheboygan, WI) from 1989 to 2026: 46 510(k) clearances. Most are in product codes EJF (Bracket, Metal, Orthodontic) and DYH (Adhesive, Bracket And Tooth Conditioner, Resin). Since 2016 its 510(k)s took a median of 3 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “American Orthodontics Corp.”.

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 American Orthodontics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2008: 12012: 12015: 12016: 12018: 22020: 12023: 12024: 12026 (partial year): 1
2007high 2 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like American Orthodontics’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?

  • EJFBracket, Metal, Orthodontic22decisions
  • DYHAdhesive, Bracket And Tooth Conditioner, Resin8decisions
  • NJMBracket, Ceramic, Orthodontic3decisions
  • KMYPositioner, Tooth, Preformed2decisions
  • KLEAgent, Tooth Bonding, Resin2decisions
  • KHRAbsorber, Saliva, Paper1decision

Also: EMA (1), ECI (1), DYW (1), DYJ (1), FJF (1), EBI (1).

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 3 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 124 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K080749RadianceAmerican Orthodontics · 20084cite it
  • K172953Acid EtchantAmerican Orthodontics · 20182cite it
  • K160782BracePaste AdhesiveAmerican Orthodontics · 20161cites it
  • K122753Empower ClearAmerican Orthodontics · 20121cites it

What has FDA decided for it lately?

  • K261840BracePaste Prime PlusAmerican Orthodontics · 2026
  • K242537BracePaste Fluoride SealantAmerican Orthodontics Corp. · 2024
  • K232011CleoAmerican Orthodontics · 2023
  • K202276BracePaste Band and Build LCAmerican Orthodontics · 2020
  • K181910BracePaste MTP Light Cure PrimerAmerican Orthodontics · 2018
  • K172953Acid EtchantAmerican Orthodontics · 2018
  • K160782BracePaste AdhesiveAmerican Orthodontics · 2016
  • K143117Wire Sterilization Package with IndicatorsAmerican Orthodontics · 2015

All 45 as American Orthodontics →The one decision as American Orthodontics Corp. →