510(k) Report

FDA applicant

Oco Biomedical

Albuquerque, NM4 decisions2008–20130 recalls

FDA records 4 decisions for Oco Biomedical (Albuquerque, NM) from 2008 to 2013: 4 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 25 predicates, 3 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 Oco Biomedical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2008: 12009: 12012: 12013: 1
2008high 1 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Oco Biomedical by year, 2008–2026Sources: 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-Form4decisions

Whose devices does it build on?

Its devices cite 25 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 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.

  • K090174Tsi; EriOco Biomedical · 20094cite it
  • K110337Universal Maxillary MolarOco Biomedical · 20121cites it
  • K080115I-Mini Dental ImplantOco Biomedical · 20081cites it

What has FDA decided for it lately?

  • K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical · 2013
  • K110337Universal Maxillary MolarOco Biomedical · 2012
  • K090174Tsi; EriOco Biomedical · 2009
  • K080115I-Mini Dental ImplantOco Biomedical · 2008

All 4 as Oco Biomedical →