510(k) Report

FDA applicant

Enamelite, LLC

Austin, TX2 decisions2003–20090 recalls

FDA records 2 decisions for Enamelite, LLC (Austin, TX) from 2003 to 2009: 2 510(k) clearances. Most are in product codes EBD (Coating, Filling Material, Resin) and EIH (Powder, Porcelain). 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 Enamelite, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Enamelite, LLC 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?

  • EBDCoating, Filling Material, Resin1decision
  • EIHPowder, Porcelain1decision

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 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.

  • K030859Nova Ceramic Spray Glaze and Tru-Paque, Opaque PorcelainEnamelite, LLC · 20032cite it

What has FDA decided for it lately?

  • K093019Enamelite Acryseal Spray SealantEnamelite, LLC · 2009
  • K030859Nova Ceramic Spray Glaze and Tru-Paque, Opaque PorcelainEnamelite, LLC · 2003

All 2 as Enamelite, LLC →