510(k) Report

FDA applicant

Royal Industries (Thailand) Public Co., Ltd.

Krathumban, TH1 decision2005–20050 recalls

FDA records 1 decision for Royal Industries (Thailand) Public Co., Ltd. (Krathumban, TH) in 2005: 1 510(k) clearance. All are in product code KKO (Ring, Teething, Fluid-Filled). 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 Royal Industries (Thailand) Public Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Royal Industries (Thailand) Public Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Royal Industries (Thailand) Public Co., Ltd. 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?

  • KKORing, Teething, Fluid-Filled1decision

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.

  • K052105Water Filled TeetherRoyal Industries (Thailand) Public Co., Ltd. · 20051cites it

What has FDA decided for it lately?

  • K052105Water Filled TeetherRoyal Industries (Thailand) Public Co., Ltd. · 2005

The one decision as Royal Industries (Thailand) Public Co., Ltd. →

Other applicant names beginning “Royal”

FDA records each applicant name separately; these may or may not be the same firm.

Royal American Industries, Inc. 2Royal Enterprises Manufacturing, Inc. 2Royal Oak Medical Devices 2Royal Precision Plastics, Inc. 1Royal King Infant Products Co., Ltd. 1Royal Flash Enterprise Co., Ltd. 1Royal Shine Enterprises, Ltd. 1Royal Scientific, Inc. 1Royal Dental Lab 1Royal Plastic Sarl 1Royal Pacific Intl. Trade, Inc. 1