510(k) Report

FDA applicant

Hati Dental Ag.

Ridley Park, PA1 decision2001–20010 recalls

FDA records 1 decision for Hati Dental Ag. (Ridley Park, PA) in 2001: 1 510(k) clearance. All are in product code DZE (Implant, Endosseous, Root-Form). 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 Hati Dental Ag.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hati Dental Ag. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hati Dental Ag. 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?

  • DZEImplant, Endosseous, Root-Form1decision

Who builds on its devices?

Later devices cite its devices 5 times; 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.

  • K003045HA-TI (Hand Titanium Screw) ImplantHati Dental Ag. · 20015cite it

What has FDA decided for it lately?

  • K003045HA-TI (Hand Titanium Screw) ImplantHati Dental Ag. · 2001

The one decision as Hati Dental Ag. →