510(k) Report

FDA applicant

Nsk America Corp.

Richardson, TX2 decisions2005–20130 recalls

FDA records 2 decisions for Nsk America Corp. (Richardson, TX) from 2005 to 2013: 2 510(k) clearances. All are in product code EFB (Handpiece, Air-Powered, Dental). Its devices cite 1 predicate, 1 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 Nsk America Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Nsk America Corp.’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?

  • EFBHandpiece, Air-Powered, Dental2decisions

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K052700Pana-SprayNsk America Corp. · 20053cite it
  • K131014Pana Spray PlusNsk America Corp. · 20132cite it

What has FDA decided for it lately?

  • K131014Pana Spray PlusNsk America Corp. · 2013
  • K052700Pana-SprayNsk America Corp. · 2005

All 2 as Nsk America Corp. →