510(k) Report

FDA applicant

Dentek Lasersystems Produktions Ges.M.B.H.

Chicago, IL2 decisions1998–19990 recalls

FDA records 2 decisions for Dentek Lasersystems Produktions Ges.M.B.H. (Chicago, IL) from 1998 to 1999: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). 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, general and plastic surgery panel, where it files most

How often FDA has decided Dentek Lasersystems Produktions Ges.M.B.H.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dentek Lasersystems Produktions Ges.M.B.H. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dentek Lasersystems Produktions Ges.M.B.H. 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?

  • GEXPowered Laser Surgical Instrument2decisions

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.

  • K974057Dentek LD 15 LasersystemDentek Lasersystems Produktions Ges.M.B.H. · 19981cites it

What has FDA decided for it lately?

  • K990680Dentec LD 15 Diode LaserDentek Lasersystems Produktions Ges.M.B.H. · 1999
  • K974057Dentek LD 15 LasersystemDentek Lasersystems Produktions Ges.M.B.H. · 1998

All 2 as Dentek Lasersystems Produktions Ges.M.B.H. →

Other applicant names beginning “Dentek”

FDA records each applicant name separately; these may or may not be the same firm.

Dentek Corp. 1