510(k) Report

FDA applicant

Aidi Biomedical, LLC

Wildomar, CA2 decisions2010–20130 recalls

FDA records 2 decisions for Aidi Biomedical, LLC (Wildomar, CA) from 2010 to 2013: 2 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 4 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 Aidi Biomedical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2010: 12013: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Aidi Biomedical, LLC 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?

  • DZEImplant, Endosseous, Root-Form2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K101755Aidi Dental Implant SystemAidi Biomedical, LLC · 20101cites it

What has FDA decided for it lately?

  • K123861Aidi Dental Implant SystemAidi Biomedical, LLC · 2013
  • K101755Aidi Dental Implant SystemAidi Biomedical, LLC · 2010

All 2 as Aidi Biomedical, LLC →