510(k) Report

FDA applicant

Dmg Chemisch Pharmazeutische Fabrik GmbH

Hamburg, DE4 decisions1994–20220 recalls

FDA records 4 decisions for Dmg Chemisch Pharmazeutische Fabrik GmbH (Hamburg, DE) from 1994 to 2022: 4 510(k) clearances. Most are in product codes EBG (Crown And Bridge, Temporary, Resin) and EMA (Cement, Dental). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “DMG Chemisch-Pharmazeutische Fabrik GmbH”.

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 Chemisch Pharmazeutische Fabrik GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2019: 12022: 1
2007high 1 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dmg Chemisch Pharmazeutische Fabrik GmbH 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?

  • EBGCrown And Bridge, Temporary, Resin2decisions
  • EMACement, Dental2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K924830Luxatemp AutomixDmg Chemisch Pharmazeutische Fabrik GmbH · 19944cite it

What has FDA decided for it lately?

  • K213201DeltaFil, DeltaFil ConditionerDMG Chemisch-Pharmazeutische Fabrik GmbH · 2022
  • K183337LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2DMG Chemisch-Pharmazeutische Fabrik GmbH · 2019
  • K991172Ionosit BondDmg Chemisch Pharmazeutische Fabrik GmbH · 1999
  • K924830Luxatemp AutomixDmg Chemisch Pharmazeutische Fabrik GmbH · 1994

All 2 as Dmg Chemisch Pharmazeutische Fabrik GmbH →All 2 as DMG Chemisch-Pharmazeutische Fabrik GmbH →