510(k) Report

FDA applicant

Mk-Dent GmbH

Kumhausen, DE2 decisions2003–20050 recalls

FDA records 2 decisions for Mk-Dent GmbH (Kumhausen, DE) from 2003 to 2005: 2 510(k) clearances. All are in product code EFB (Handpiece, Air-Powered, Dental). Its devices cite 5 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 Mk-Dent GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mk-Dent GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mk-Dent 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?

  • EFBHandpiece, Air-Powered, Dental2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K051872MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings, and Light Power System, Models…Mk-Dent GmbH · 20051cites it
  • K032234MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS 6021K, 6011K, 6012KMk-Dent GmbH · 20031cites it

What has FDA decided for it lately?

  • K051872MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings, and Light Power System, Models…Mk-Dent GmbH · 2005
  • K032234MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS 6021K, 6011K, 6012KMk-Dent GmbH · 2003

All 2 as Mk-Dent GmbH →