510(k) Report

FDA applicant

Mathys Corp. of North America

Malvern, PA1 decision1991–19910 recalls

FDA records 1 decision for Mathys Corp. of North America (Malvern, PA) in 1991: 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 Mathys Corp. of North America’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mathys Corp. of North America since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mathys Corp. of North America 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 4 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.

  • K901927HA-TI (Hand-Titanium Screw) ImplantMathys Corp. of North America · 19914cite it

What has FDA decided for it lately?

  • K901927HA-TI (Hand-Titanium Screw) ImplantMathys Corp. of North America · 1991

The one decision as Mathys Corp. of North America →

Other applicant names beginning “Mathys”

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

Mathys Corp. 2