510(k) Report

FDA applicant

Wykle Research, Inc.

Carson City, NV3 decisions1991–19950 recalls

FDA records 3 decisions for Wykle Research, Inc. (Carson City, NV) from 1991 to 1995: 3 510(k) clearances. Most are in product codes EFD (Amalgamator, Dental, Ac-Powered) and EJJ (Alloy, Amalgam). 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 Wykle Research, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wykle Research, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wykle Research, Inc. 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?

  • EFDAmalgamator, Dental, Ac-Powered1decision
  • EJJAlloy, Amalgam1decision
  • ELWMaterial, Impression1decision

What has FDA decided for it lately?

  • K952670CupralloyWykle Research, Inc. · 1995
  • K9215711ST ImpressionWykle Research, Inc. · 1993
  • K910632Accu-Mix AmalgamatorWykle Research, Inc. · 1991

All 3 as Wykle Research, Inc. →