510(k) Report

FDA applicant

Sherpa Korea

Hudson, NH1 decision2011–20110 recalls

FDA records 1 decision for Sherpa Korea (Hudson, NH) in 2011: 1 510(k) clearance. All are in product code ELW (Material, Impression). 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 Sherpa Korea’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Sherpa Korea by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ELWMaterial, Impression1decision

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.

  • K103346Delikit Putty, Delikit Heavy Body, Delikit Light BodySherpa Korea · 20111cites it

What has FDA decided for it lately?

  • K103346Delikit Putty, Delikit Heavy Body, Delikit Light BodySherpa Korea · 2011

The one decision as Sherpa Korea →