510(k) Report

FDA applicant

Xpdent Corp

Miami, FL3 decisions2006–20080 recalls

FDA records 3 decisions for Xpdent Corp (Miami, FL) from 2006 to 2008: 3 510(k) clearances. Most are in product codes EIH (Powder, Porcelain) and ELM (Denture, Plastic, Teeth). 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 Xpdent Corp’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Xpdent Corp 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, Porcelain2decisions
  • ELMDenture, Plastic, Teeth1decision

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.

  • K061337Wiedent EsteticXpdent Corp · 20062cite it

What has FDA decided for it lately?

  • K082158Denseo FairyXpdent Corp · 2008
  • K071201Zeo CE Light & Zeo Quick PorcelainXpdent Corp · 2007
  • K061337Wiedent EsteticXpdent Corp · 2006

All 3 as Xpdent Corp →