510(k) Report

FDA applicant

Den-Mat Holdings, LLC

Lompoc, CA9 decisions2008–20260 recalls

FDA records 9 decisions for Den-Mat Holdings, LLC (Lompoc, CA) from 2008 to 2026: 9 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and KLE (Agent, Tooth Bonding, Resin). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 15 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 Den-Mat Holdings, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2008: 22010: 12011: 12014: 12015: 12017: 12024: 12026 (partial year): 1
2008high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Den-Mat Holdings, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EBFMaterial, Tooth Shade, Resin3decisions
  • KLEAgent, Tooth Bonding, Resin2decisions
  • GEXPowered Laser Surgical Instrument2decisions
  • NXVDiagnostic Light, Soft Tissue Detector1decision
  • EBZActivator, Ultraviolet, For Polymerization1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 89 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 108 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 15 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K103667Sapphire ST Portable Diode LaserDen-Mat Holdings, LLC · 20102cite it
  • K073483Sapphire O/E Oral Examination SystemDen-Mat Holdings, LLC · 20081cites it

What has FDA decided for it lately?

  • K262252MPa Max adhesiveDen-Mat Holdings, LLC · 2026
  • K242097DenMat Bulk Fill CompositeDen-Mat Holdings, LLC · 2024
  • K162967nuance UNIVERSALDen-Mat Holdings, LLC · 2017
  • K143679Nuance FLOWDen-Mat Holdings, LLC · 2015
  • K140537TENURE4GDen-Mat Holdings, LLC · 2014
  • K110079Spphine Plus STM 3W Diode LaserDen-Mat Holdings, LLC · 2011
  • K103667Sapphire ST Portable Diode LaserDen-Mat Holdings, LLC · 2010
  • K081287Sapphire Plasma Arc Dental Curing LightDen-Mat Holdings, LLC · 2008

All 9 as Den-Mat Holdings, LLC →