510(k) Report

FDA applicant

Thommen Medical AG

San Diego, CA26 decisions2002–20171 recall

FDA records 26 decisions for Thommen Medical AG (San Diego, CA) from 2002 to 2017: 26 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and DZE (Implant, Endosseous, Root-Form). Since 2016 its 510(k)s took a median of 122 days from receipt to decision, against 202 for FDA’s reviews in the same codes and years. Its devices cite 56 predicates, 28 of them its own earlier devices. 1 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 Thommen Medical AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007: 62008: 12009: 32010: 22011: 22012: 12016: 22017: 1
2007high 6 (2007) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2007

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

Class I Class II/III not classified

FIG. 1 — Thommen Medical AG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Thommen Medical AG’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?

  • NHAAbutment, Implant, Dental, Endosseous16decisions
  • DZEImplant, Endosseous, Root-Form9decisions
  • NDPAccessories, Implant, Dental, Endosseous1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 122 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 202 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 56 predicates; 28 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 42 times; 28 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.

  • K031747Spi Dental Implant AbutmentsThommen Medical AG · 20037cite it
  • K023645Spi Easy Dental Implant AbutmentThommen Medical AG · 20024cite it
  • K102804Spi Titanium Base for Cad/CamThommen Medical AG · 20114cite it
  • K090153Spi Variomulti Angled AbutmentThommen Medical AG · 20093cite it
  • K071453Spi Easy 4.0 AbutmentThommen Medical AG · 20073cite it
  • K072856Spi Variomulti AbutmentThommen Medical AG · 20083cite it

What has FDA decided for it lately?

  • K171795Thommen Implant SystemThommen Medical AG · 2017
  • K160244VARIOuniteThommen Medical AG · 2016
  • K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG · 2016
  • K121334VarioecoThommen Medical AG · 2012
  • K111984Spi Vario Angled AbutmentThommen Medical AG · 2011
  • K102804Spi Titanium Base for Cad/CamThommen Medical AG · 2011
  • K101798Spi Variomulti Angled AbutmentThommen Medical AG · 2010
  • K093615Spi Dental Implant, ElementThommen Medical AG · 2010

All 26 as Thommen Medical AG →

What has been recalled?

1 recall linked to its devices; the latest:

  • K023645SPI EASY Abutment. Endosseous dental implant abutment.Apr 19, 2007