510(k) Report

FDA applicant

W&H Dentalwerk Buermoss GmbH

Buermoos, AT2 decisions2022–20230 recalls

FDA records 2 decisions for W&H Dentalwerk Buermoss GmbH (Buermoos, AT) from 2022 to 2023: 2 510(k) clearances. Most are in product codes ELC (Scaler, Ultrasonic) and ERL (Drill, Surgical, Ent (Electric Or Pneumatic)…). Its devices cite 2 predicates, 0 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 W&H Dentalwerk Buermoss GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2022: 12023: 1
2022high 1 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — W&H Dentalwerk Buermoss GmbH by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ELCScaler, Ultrasonic1decision
  • ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH · 20221cites it

What has FDA decided for it lately?

  • K223173Proxeo ULTRA (PB-510, PB-520 and PB-530)W&H Dentalwerk Buermoss GmbH · 2023
  • K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH · 2022

All 2 as W&H Dentalwerk Buermoss GmbH →