510(k) Report

FDA applicant

Brainbase Corporation

Shinagawa-Ku Tokyo, JP3 decisions2006–20090 recalls

FDA records 3 decisions for Brainbase Corporation (Shinagawa-Ku Tokyo, JP) from 2006 to 2009: 3 510(k) clearances. Most are in product codes KOJ (Airbrush) and LYC (Bone Grafting Material, Synthetic). Its devices cite 8 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 Brainbase Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 12009: 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 — Brainbase Corporation 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?

  • KOJAirbrush1decision
  • LYCBone Grafting Material, Synthetic1decision
  • DZEImplant, Endosseous, Root-Form1decision

Whose devices does it build on?

Its devices cite 8 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.

  • K083372Arrowbone-a, Arrowbone-BBrainbase Corporation · 20091cites it

What has FDA decided for it lately?

  • K083372Arrowbone-a, Arrowbone-BBrainbase Corporation · 2009
  • K063236Beta-PowderBrainbase Corporation · 2007
  • K052254Mytis Arrow XXXXBrainbase Corporation · 2006

All 3 as Brainbase Corporation →