510(k) Report

FDA applicant

Mam International AG

White Plains, NY2 decisions2010–20100 recalls

FDA records 2 decisions for Mam International AG (White Plains, NY) in 2010: 2 510(k) clearances. All are in product code KKO (Ring, Teething, Fluid-Filled). 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 Mam International AG’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2010: 2
2010high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Mam International AG by year, 2010–2026Sources: 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-Filled2decisions

Whose devices does it build on?

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

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.

  • K092781Mam TwisterMam International AG · 20101cites it

What has FDA decided for it lately?

  • K093266Mam CoolerMam International AG · 2010
  • K092781Mam TwisterMam International AG · 2010

All 2 as Mam International AG →