510(k) Report

FDA applicant

American Dentronics, Inc.

Las Vegas, NV4 decisions1994–19980 recalls

FDA records 4 decisions for American Dentronics, Inc. (Las Vegas, NV) from 1994 to 1998: 4 510(k) clearances. Most are in product codes JEQ (Toothbrush, Powered) and LCN (Scraper, Tongue). 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 American Dentronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Dentronics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JEQToothbrush, Powered3decisions
  • LCNScraper, Tongue1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K980075CybersonicAmerican Dentronics, Inc. · 19981cites it

What has FDA decided for it lately?

  • K980075CybersonicAmerican Dentronics, Inc. · 1998
  • K935150SoniplakAmerican Dentronics, Inc. · 1994
  • K935149SonibrushAmerican Dentronics, Inc. · 1994
  • K935148SoniflossAmerican Dentronics, Inc. · 1994

All 4 as American Dentronics, Inc. →