510(k) Report

FDA applicant

Paxmed International

San Diego, CA4 decisions2001–20120 recalls

FDA records 4 decisions for Paxmed International (San Diego, CA) from 2001 to 2012: 4 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and KIF (Resin, Root Canal Filling). 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 Paxmed International’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Paxmed International 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?

  • DZEImplant, Endosseous, Root-Form3decisions
  • KIFResin, Root Canal Filling1decision

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 6 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.

  • K022038Spi Onetime Dental ImplantPaxmed International · 20022cite it
  • K113568Mta-FillapexPaxmed International · 20122cite it
  • K011223Quantum Versatility (QVS) Dental Implant SystemPaxmed International · 20011cites it
  • K010467Universal Dental Coping (Udc)Paxmed International · 20011cites it

What has FDA decided for it lately?

  • K113568Mta-FillapexPaxmed International · 2012
  • K022038Spi Onetime Dental ImplantPaxmed International · 2002
  • K010467Universal Dental Coping (Udc)Paxmed International · 2001
  • K011223Quantum Versatility (QVS) Dental Implant SystemPaxmed International · 2001

All 4 as Paxmed International →