510(k) Report

FDA applicant

Rite-Dent Manufacturing Corp.

Hialeah, FL7 decisions2001–20021 recall

FDA records 7 decisions for Rite-Dent Manufacturing Corp. (Hialeah, FL) from 2001 to 2002: 7 510(k) clearances. Most are in product codes EMA (Cement, Dental) and LBH (Varnish, Cavity). 1 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 Rite-Dent Manufacturing Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rite-Dent Manufacturing Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rite-Dent Manufacturing 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?

  • EMACement, Dental2decisions
  • LBHVarnish, Cavity1decision
  • ELWMaterial, Impression1decision
  • EBCSealant, Pit And Fissure, And Conditioner1decision
  • KLEAgent, Tooth Bonding, Resin1decision
  • EBFMaterial, Tooth Shade, Resin1decision

What has FDA decided for it lately?

  • K020050Enamel Bonding SystemRite-Dent Manufacturing Corp. · 2002
  • K011822Pit and Fissure Chemical Curing SealantRite-Dent Manufacturing Corp. · 2001
  • K011453Tooth Shade Resin MaterialRite-Dent Manufacturing Corp. · 2001
  • K010255Cavity VarnishRite-Dent Manufacturing Corp. · 2001
  • K010240Polycarboxylate (Pca) CementRite-Dent Manufacturing Corp. · 2001
  • K003427Zinc Phosphate CementRite-Dent Manufacturing Corp. · 2001
  • K003426Alginate Impression MaterialRite-Dent Manufacturing Corp. · 20011 recall

All 7 as Rite-Dent Manufacturing Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K003426Product names: a) Alginate Dental Impression Material Regular Set, Cinnamon Flavor, Pink…Sep 21, 2005