510(k) Report

FDA applicant

C-Mix

New Port Riche, FL2 decisions2000–20000 recalls

FDA records 2 decisions for C-Mix (New Port Riche, FL) in 2000: 2 510(k) clearances. Most are in product codes EIH (Powder, Porcelain) and EJH (Alloy, Metal, Base). 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 C-Mix’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for C-Mix since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — C-Mix 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?

  • EIHPowder, Porcelain1decision
  • EJHAlloy, Metal, Base1decision

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.

  • K000983Ceramix Porcelain SystemC-Mix · 20001cites it

What has FDA decided for it lately?

  • K000983Ceramix Porcelain SystemC-Mix · 2000
  • K000981Ceramix EZ Cast, Ceramix EZ Cast Solder, Ceramix EZ Cast FluxC-Mix · 2000

All 2 as C-Mix →