510(k) Report

FDA applicant

Lumalite, Inc.

Los Angeles, CA3 decisions1999–20020 recalls

FDA records 3 decisions for Lumalite, Inc. (Los Angeles, CA) from 1999 to 2002: 3 510(k) clearances. Most are in product codes EIA (Unit, Operative Dental) and EBZ (Activator, Ultraviolet, For Polymerization). Its devices cite 3 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 Lumalite, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lumalite, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lumalite, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lumalite, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EIAUnit, Operative Dental1decision
  • EBZActivator, Ultraviolet, For Polymerization1decision
  • EBFMaterial, Tooth Shade, Resin1decision

Whose devices does it build on?

Its devices cite 3 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.

  • K021083VeracamLumalite, Inc. · 20021cites it

What has FDA decided for it lately?

  • K021083VeracamLumalite, Inc. · 2002
  • K002566Lumalite Cure Light, Model 2100Lumalite, Inc. · 2000
  • K992102Luma Light 2000 Cure LightLumalite, Inc. · 1999

All 3 as Lumalite, Inc. →