510(k) Report

FDA applicant

Dental/Medical Diagnostic Systems, Inc.

Irvine, CA3 decisions1998–19990 recalls

FDA records 3 decisions for Dental/Medical Diagnostic Systems, Inc. (Irvine, CA) from 1998 to 1999: 3 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and EIA (Unit, Operative Dental). 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 Dental/Medical Diagnostic Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dental/Medical Diagnostic Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dental/Medical Diagnostic Systems, 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?

  • MUHSystem, X-Ray, Extraoral Source, Digital1decision
  • EIAUnit, Operative Dental1decision
  • EBFMaterial, Tooth Shade, Resin1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K981948Apollo 95EDental/Medical Diagnostic Systems, Inc. · 19982cite it
  • K980474TelicamDental/Medical Diagnostic Systems, Inc. · 19981cites it

What has FDA decided for it lately?

  • K990087DMD Digital X-Ray SystemDental/Medical Diagnostic Systems, Inc. · 1999
  • K981948Apollo 95EDental/Medical Diagnostic Systems, Inc. · 1998
  • K980474TelicamDental/Medical Diagnostic Systems, Inc. · 1998

All 3 as Dental/Medical Diagnostic Systems, Inc. →