510(k) Report

FDA applicant

Nsi

Fairfax, VA3 decisions2001–20120 recalls

FDA records 3 decisions for Nsi (Fairfax, VA) from 2001 to 2012: 3 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 9 predicates, 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 Nsi’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 9 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 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.

  • K003620Nsi Hexed and Non-Hexed Implant SystemNsi · 200110cite it
  • K020617Nsi Hexed and Non-Hexed Implant SystemNsi · 20029cite it

What has FDA decided for it lately?

  • K120581SC Tip CleanerNsi · 2012
  • K020617Nsi Hexed and Non-Hexed Implant SystemNsi · 2002
  • K003620Nsi Hexed and Non-Hexed Implant SystemNsi · 2001

All 3 as Nsi →