510(k) Report

FDA applicant

Dental Direkt of Amerika UG (Haftungsbeschraenkt)

Spenge, DE2 decisions2010–20150 recalls

FDA records 2 decisions for Dental Direkt of Amerika UG (Haftungsbeschraenkt) (Spenge, DE) from 2010 to 2015: 2 510(k) clearances. All are in product code EIH (Powder, Porcelain). Its devices cite 4 predicates, 1 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 Dental Direkt of Amerika UG (Haftungsbeschraenkt)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2010: 12015: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Dental Direkt of Amerika UG (Haftungsbeschraenkt) by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dental Direkt of Amerika UG…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • EIHPowder, Porcelain2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K093748DD Bio Z and DD Bio Z - TranspaDental Direkt of Amerika UG (Haftungsbeschraenkt) · 20103cite it
  • K142987DD Bio Z, DD Bio ZX (square), DD BioZX (square) colorDental Direkt of Amerika UG (Haftungsbeschraenkt) · 20152cite it

What has FDA decided for it lately?

  • K142987DD Bio Z, DD Bio ZX (square), DD BioZX (square) colorDental Direkt of Amerika UG (Haftungsbeschraenkt) · 2015
  • K093748DD Bio Z and DD Bio Z - TranspaDental Direkt of Amerika UG (Haftungsbeschraenkt) · 2010

All 2 as Dental Direkt of Amerika UG (Haftungsbeschraenkt) →