510(k) Report

FDA applicant

Discus Dental, Inc.

Culver City, CA15 decisions2002–20102 recalls

FDA records 15 decisions for Discus Dental, Inc. (Culver City, CA) from 2002 to 2010: 15 510(k) clearances. Most are in product codes EBZ (Activator, Ultraviolet, For Polymerization) and ELW (Material, Impression). Its devices cite 15 predicates, 2 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Discus Dental, LLC”.

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 Discus Dental, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2010

2007: 22009: 12010: 4
2007high 4 (2010) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2014

2011: 12014: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Discus Dental, 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?

  • EBZActivator, Ultraviolet, For Polymerization3decisions
  • ELWMaterial, Impression3decisions
  • ELCScaler, Ultrasonic2decisions
  • LBHVarnish, Cavity1decision
  • GEXPowered Laser Surgical Instrument1decision
  • EJRAgent, Polishing, Abrasive, Oral Cavity1decision

Also: MED (1), EKX (1), EBF (1), KIF (1).

Whose devices does it build on?

Its devices cite 15 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 2 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.

  • K040053Precision VPS Impression MaterialDiscus Dental, Inc. · 20044cite it
  • K052090Splash! Impression Material DeviceDiscus Dental, Inc. · 20052cite it
  • K062176Relief Acp Oral Care GelDiscus Dental, Inc. · 20071cites it
  • K102639SL3Discus Dental, LLC · 20101cites it
  • K030776Mega Bite Registration - Dental Bite Registration MaterialDiscus Dental, Inc. · 20031cites it
  • K101612Zen Cordless Prophy SystemDiscus Dental, LLC · 20101cites it

What has FDA decided for it lately?

  • K102639SL3Discus Dental, LLC · 20101 recall
  • K101612Zen Cordless Prophy SystemDiscus Dental, LLC · 2010
  • K101215NuanceDiscus Dental, LLC · 2010
  • K093208SimplisealDiscus Dental, LLC · 2010
  • K092417Insight Ultrasonic InsertsDiscus Dental, LLC · 2009
  • K073518Flashlite Rebel*Discus Dental, Inc. · 2007
  • K062176Relief Acp Oral Care GelDiscus Dental, Inc. · 20071 recall
  • K052090Splash! Impression Material DeviceDiscus Dental, Inc. · 2005

All 10 as Discus Dental, Inc. →All 5 as Discus Dental, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K062176Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold…Oct 24, 2014Class II
  • K102639SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street…Jul 21, 2011Class II