510(k) Report

FDA applicant

Hass Corp.

Gangneung-Si, KR6 decisions2010–20260 recalls

FDA records 6 decisions for Hass Corp. (Gangneung-Si, KR) from 2010 to 2026: 6 510(k) clearances. All are in product code EIH (Powder, Porcelain). Since 2016 its 510(k)s took a median of 132 days from receipt to decision, against 102 for FDA’s reviews in the same codes and years. Its devices cite 7 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 Hass Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2010: 12011: 12016: 12021: 12026 (partial year): 2
2010high 2 (2026) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Hass Corp. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EIHPowder, Porcelain6decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 132 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 102 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 7 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.

  • K202952Amber Mill Q Series & Amber Mill Direct SeriesHass Corp. · 20211cites it

What has FDA decided for it lately?

  • K262523Amber ArteHass Corp. · 2026
  • K260859Rosetta SM, Rosetta SPHass Corp. · 2026
  • K202952Amber Mill Q Series & Amber Mill Direct SeriesHass Corp. · 2021
  • K160102Amber Mill Series and Amber Press SeriesHass Corp. · 2016
  • K111573Monobloc BM SeriesHass Corp. · 2011
  • K102305Hass Zirtooth Model Zortooth H. Zirtooth T. Zirtoothc, Zirtooth PHass Corp. · 2010

All 6 as Hass Corp. →