510(k) Report

FDA applicant

Dmg USA, Inc.

Ayer, MA28 decisions2000–20180 recalls

FDA records 28 decisions for Dmg USA, Inc. (Ayer, MA) from 2000 to 2018: 28 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EBG (Crown And Bridge, Temporary, Resin). Its devices cite 66 predicates, 8 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 USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007: 12008: 32010: 52011: 12014: 12016: 12018: 1
2007high 5 (2010) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dmg USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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