510(k) Report

FDA applicant

Metalor

Rockville Centre, NY3 decisions1994–19940 recalls

FDA records 3 decisions for Metalor (Rockville Centre, NY) in 1994: 3 510(k) clearances. Most are in product codes EJT (Alloy, Gold-Based Noble Metal) and EJS (Alloy, Other Noble Metal). 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 Metalor’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Metalor since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Metalor 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?

  • EJTAlloy, Gold-Based Noble Metal2decisions
  • EJSAlloy, Other Noble Metal1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K944572V-Delta N (V-Delta Loy), Aurofluid 2PFMetalor · 19942cite it

What has FDA decided for it lately?

  • K944572V-Delta N (V-Delta Loy), Aurofluid 2PFMetalor · 1994
  • K935387Pontor LFCMetalor · 1994
  • K935388Cerapall 4CFMetalor · 1994

All 3 as Metalor →

Other applicant names beginning “Metalor”

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

Metalor Dental USA Corp. 67Metalor Technologies USA 4