510(k) Report

FDA applicant

Osteoready, LLC

Seattle, WA2 decisions2015–20180 recalls

FDA records 2 decisions for Osteoready, LLC (Seattle, WA) from 2015 to 2018: 2 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and DZE (Implant, Endosseous, Root-Form). 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 Osteoready, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2015: 12018: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Osteoready, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NHAAbutment, Implant, Dental, Endosseous1decision
  • DZEImplant, Endosseous, Root-Form1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K173575OsteoReady Dental Implant SystemOsteoready, LLC · 2018
  • K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC · 2015

All 2 as Osteoready, LLC →