510(k) Report

FDA applicant

Fittydent-Altwirth & Schmitt GmbH

Chicago, IL3 decisions1993–19940 recalls

FDA records 3 decisions for Fittydent-Altwirth & Schmitt GmbH (Chicago, IL) from 1993 to 1994: 3 510(k) clearances. Most are in product codes EFT (Cleanser, Denture, Over The Counter) and KGB (Mask, Oxygen, Non-Rebreathing). 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 Fittydent-Altwirth & Schmitt GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fittydent-Altwirth & Schmitt GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fittydent-Altwirth & Schmitt 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?

  • EFTCleanser, Denture, Over The Counter1decision
  • KGBMask, Oxygen, Non-Rebreathing1decision
  • KOOAdhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt1decision

What has FDA decided for it lately?

  • K930335Profast - Denture Adhesive for Lower JawsFittydent-Altwirth & Schmitt GmbH · 1994
  • K930337Profast (R)-Denture CleanserFittydent-Altwirth & Schmitt GmbH · 1993
  • K930336Profast (R)-Denture Adhesive CreamFittydent-Altwirth & Schmitt GmbH · 1993

All 3 as Fittydent-Altwirth & Schmitt GmbH →