510(k) Report

FDA applicant

Dmg America, LLC

Ayer, MA1 decision2013–20130 recalls

FDA records 1 decision for Dmg America, LLC (Ayer, MA) in 2013: 1 510(k) clearance. All are in product code KLE (Agent, Tooth Bonding, Resin). 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 Dmg America, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Dmg America, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KLEAgent, Tooth Bonding, Resin1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K131248Etch GelDmg America, LLC · 2013

The one decision as Dmg America, LLC →