510(k) Report

FDA applicant

Dentalpoint AG

Zurich, CH4 decisions2014–20180 recalls

FDA records 4 decisions for Dentalpoint AG (Zurich, CH) from 2014 to 2018: 4 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 297 days from receipt to decision, against 219 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 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 Dentalpoint AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2014: 12016: 22018: 1
2014high 2 (2016) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Dentalpoint AG by year, 2014–2026Sources: 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
  • NHAAbutment, Implant, Dental, Endosseous1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 297 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 219 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K133255Zeramex T and Zeramex Plus Dental Implant SystemsDentalpoint AG · 20142cite it
  • K152385Zeramex P6 Dental Implant SystemDentalpoint AG · 20161cites it

What has FDA decided for it lately?

  • K180184Zeramex (R) XT Dental Implant System, NobelPearl Dental Implant SystemDentalpoint AG · 2018
  • K163043Zeramex P6 Dental Implant SystemDentalpoint AG · 2016
  • K152385Zeramex P6 Dental Implant SystemDentalpoint AG · 2016
  • K133255Zeramex T and Zeramex Plus Dental Implant SystemsDentalpoint AG · 2014

All 4 as Dentalpoint AG →