510(k) Report

FDA applicant

Juell Dental

Ardmore, OK3 decisions2011–20110 recalls

FDA records 3 decisions for Juell Dental (Ardmore, OK) in 2011: 3 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and DZE (Implant, Endosseous, Root-Form). Its devices cite 4 predicates, 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 Juell Dental’s devices, and how often a recall has named them.

FDA decisions per year

3in 2011

2011: 3
2011high 3 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Juell Dental by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EBIResin, Denture, Relining, Repairing, Rebasing2decisions
  • DZEImplant, Endosseous, Root-Form1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K110548Osi O-Ball Abutment Head ImplantsJuell Dental · 20111cites it

What has FDA decided for it lately?

  • K111177Juell Hard CureJuell Dental · 2011
  • K111178Juell Soft CureJuell Dental · 2011
  • K110548Osi O-Ball Abutment Head ImplantsJuell Dental · 2011

All 3 as Juell Dental →