510(k) Report

FDA applicant

Bioinfera, Inc.

Beachwood, OH2 decisions2005–20070 recalls

FDA records 2 decisions for Bioinfera, Inc. (Beachwood, OH) from 2005 to 2007: 2 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and DZE (Implant, Endosseous, Root-Form). Its devices cite 2 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 Bioinfera, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bioinfera, Inc. by year, 2007–2026Sources: 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 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K043428Reliadent Dental Implant SystemBioinfera, Inc. · 20052cite it
  • K061323Modification to Reliadent Dental Implant SystemBioinfera, Inc. · 20072cite it

What has FDA decided for it lately?

  • K061323Modification to Reliadent Dental Implant SystemBioinfera, Inc. · 2007
  • K043428Reliadent Dental Implant SystemBioinfera, Inc. · 2005

All 2 as Bioinfera, Inc. →