510(k) Report

FDA applicant

Denterprise International, Inc.

Ormond Beach, FL4 decisions2012–20230 recalls

FDA records 4 decisions for Denterprise International, Inc. (Ormond Beach, FL) from 2012 to 2023: 4 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and EHD (Unit, X-Ray, Extraoral With Timer). 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 Denterprise International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2012: 12015: 12018: 12023: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Denterprise International, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MUHSystem, X-Ray, Extraoral Source, Digital2decisions
  • EHDUnit, X-Ray, Extraoral With Timer2decisions

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 10 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.

  • K151926QuickRay HD Intraoral SensorDenterprise International, Inc. · 20157cite it
  • K180561MobileX Portable X-ray SystemDenterprise International, Inc. · 20182cite it
  • K122582Dental X-Ray Z70 (W); Dental X-Ray Z70 (M); Dental X-Ray Z70 (C)Denterprise International, Inc. · 20121cites it

What has FDA decided for it lately?

  • K231202QuickRayPRODenterprise International, Inc. · 2023
  • K180561MobileX Portable X-ray SystemDenterprise International, Inc. · 2018
  • K151926QuickRay HD Intraoral SensorDenterprise International, Inc. · 2015
  • K122582Dental X-Ray Z70 (W); Dental X-Ray Z70 (M); Dental X-Ray Z70 (C)Denterprise International, Inc. · 2012

All 4 as Denterprise International, Inc. →