510(k) Report

FDA applicant

Csm Implant

Brea, CA4 decisions2011–20180 recalls

FDA records 4 decisions for Csm Implant (Brea, CA) from 2011 to 2018: 4 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 9 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Csm Implant Co., Ltd.”.

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 Csm Implant’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2011: 22012: 12018: 1
2011high 2 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Csm Implant by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Csm Implant’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form4decisions

Whose devices does it build on?

Its devices cite 9 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K120043CSM Internal-R Implant SystemCsm Implant · 20121cites it
  • K102635Apolonia Laser Implant SystemCsm Implant Co., Ltd. · 20111cites it
  • K111120CSM Submerged-R Implant SystemCsm Implant · 20111cites it

What has FDA decided for it lately?

  • K173141CSM Submerged3-L Implant SystemCsm Implant · 2018
  • K120043CSM Internal-R Implant SystemCsm Implant · 2012
  • K111120CSM Submerged-R Implant SystemCsm Implant · 2011
  • K102635Apolonia Laser Implant SystemCsm Implant Co., Ltd. · 2011

All 3 as Csm Implant →The one decision as Csm Implant Co., Ltd. →