510(k) Report

FDA applicant

Coopercare, Inc.

Mchenry, IL2 decisions1983–19840 recalls

FDA records 2 decisions for Coopercare, Inc. (Mchenry, IL) from 1983 to 1984: 2 510(k) clearances. Most are in product codes JET (Pick, Massaging) and ELC (Scaler, Ultrasonic). 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 Coopercare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Coopercare, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Coopercare, 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?

  • JETPick, Massaging1decision
  • ELCScaler, Ultrasonic1decision

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.

  • K834283Dentsply G-106 Cavitron UltrasonicCoopercare, Inc. · 19841cites it

What has FDA decided for it lately?

  • K834283Dentsply G-106 Cavitron UltrasonicCoopercare, Inc. · 1984
  • K832949Sanodent Double-Ended Interdental CleanCoopercare, Inc. · 1983

All 2 as Coopercare, Inc. →