510(k) Report

FDA applicant

Augma Biomaterials, Ltd.

San Diego, CA2 decisions2009–20130 recalls

FDA records 2 decisions for Augma Biomaterials, Ltd. (San Diego, CA) from 2009 to 2013: 2 510(k) clearances. All are in product code LYC (Bone Grafting Material, Synthetic). Its devices cite 3 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 Augma Biomaterials, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2009: 12013: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Augma Biomaterials, Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LYCBone Grafting Material, Synthetic2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K083858Bond BoneAugma Biomaterials, Ltd. · 20092cite it

What has FDA decided for it lately?

  • K121177Bond ApatiteAugma Biomaterials, Ltd. · 2013
  • K083858Bond BoneAugma Biomaterials, Ltd. · 2009

All 2 as Augma Biomaterials, Ltd. →