510(k) Report

FDA applicant

Fair Image, Inc.

Concord, CA1 decision1996–19960 recalls

FDA records 1 decision for Fair Image, Inc. (Concord, CA) in 1996: 1 510(k) clearance. All are in product code EHD (Unit, X-Ray, Extraoral With Timer). 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 Fair Image, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fair Image, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fair Image, 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?

  • EHDUnit, X-Ray, Extraoral With Timer1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K962631Dexis Model 601 Dental Electronic Imaging SystemFair Image, Inc. · 19961cites it

What has FDA decided for it lately?

  • K962631Dexis Model 601 Dental Electronic Imaging SystemFair Image, Inc. · 1996

The one decision as Fair Image, Inc. →

Other applicant names beginning “Fair”

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

The Fair Optical Ent.Co., Ltd. 1