510(k) Report

FDA applicant

Anaxdent GmbH

Washington, DC2 decisions2002–20120 recalls

FDA records 2 decisions for Anaxdent GmbH (Washington, DC) from 2002 to 2012: 2 510(k) clearances. Most are in product codes EBG (Crown And Bridge, Temporary, Resin) and EBF (Material, Tooth Shade, Resin). 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 Anaxdent GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Anaxdent 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, Resin1decision
  • EBFMaterial, Tooth Shade, Resin1decision

What has FDA decided for it lately?

  • K112044Anaxblend Model 20XXX (Several), Anaxgum Model 25XXX (U), Mock-UP Direct Model 240XXX (U), Mock-UP Direct…Anaxdent GmbH · 2012
  • K023079New OutlineAnaxdent GmbH · 2002

All 2 as Anaxdent GmbH →