510(k) Report

FDA applicant

Dentamerica

Industry, CA4 decisions1996–20100 recalls

FDA records 4 decisions for Dentamerica (Industry, CA) from 1996 to 2010: 4 510(k) clearances. Most are in product codes ELC (Scaler, Ultrasonic) and EKX (Handpiece, Direct Drive, Ac-Powered). Its devices cite 5 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 Dentamerica’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dentamerica’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?

  • ELCScaler, Ultrasonic1decision
  • EKXHandpiece, Direct Drive, Ac-Powered1decision
  • EHDUnit, X-Ray, Extraoral With Timer1decision
  • EBZActivator, Ultraviolet, For Polymerization1decision

Whose devices does it build on?

Its devices cite 5 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.

  • K092833Endomax Cordless Endodontic HandpieceDentamerica · 20101cites it

What has FDA decided for it lately?

  • K092833Endomax Cordless Endodontic HandpieceDentamerica · 2010
  • K060640Digirex Digital Dental Radiography SystemDentamerica · 2006
  • K954820Scalex 800Dentamerica · 1996
  • K955759LITEX 680Dentamerica · 1996

All 4 as Dentamerica →