510(k) Report

FDA applicant

Orametrix, Inc.

Dallas, TX1 decision2000–20000 recalls

FDA records 1 decision for Orametrix, Inc. (Dallas, TX) in 2000: 1 510(k) clearance. All are in product code EIA (Unit, Operative Dental). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Orametrix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orametrix, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Orametrix, 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?

  • EIAUnit, Operative Dental1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K002620Suresmile SystemOrametrix, Inc. · 2000

The one decision as Orametrix, Inc. →