510(k) Report

FDA applicant

Pure Co.

Santa Maria, CA1 decision1997–19970 recalls

FDA records 1 decision for Pure Co. (Santa Maria, CA) in 1997: 1 510(k) clearance. All are in product code 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 Pure Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pure Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pure Co. 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

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.

  • K971278Pure Company Fluid Delivery SystemPure Co. · 19972cite it

What has FDA decided for it lately?

  • K971278Pure Company Fluid Delivery SystemPure Co. · 1997

The one decision as Pure Co. →

Other applicant names beginning “Pure”

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

Pure Water, Inc. 3Pure Water Solutions, Inc. 2