510(k) Report

FDA applicant

Foundation Milling Centre

Clearwater, FL1 decision2006–20060 recalls

FDA records 1 decision for Foundation Milling Centre (Clearwater, FL) in 2006: 1 510(k) clearance. All are in product code EIH (Powder, Porcelain). 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 Foundation Milling Centre’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Foundation Milling Centre since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Foundation Milling Centre 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

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?

  • K062389Z-Block, Models 20/19, 40/19, 55/19Foundation Milling Centre · 2006

The one decision as Foundation Milling Centre →

Other applicant names beginning “Foundation”

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

Foundation Medicine, Inc. 5Foundation Surgical Group, Inc. 5Foundation Fusion Solutions, LLC (Dba Cornerloc) 2Foundation For Fluency, Inc. 1