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Hiossen implant clearances and recalls: the public record

The FDA database lists 15 endosseous implant 510(k) clearances for Hiossen, the first in 2009. Below are selected recent ones.

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FDA 510(k) clearances

  • K240232 · EK D3.3 and Ultra Wide Implants · 2024-09-13
  • K203360 · EK Implants and Abutments System · 2022-01-07
  • K183242 · ET IV SA Dental Implants · 2019-05-21
  • K153332 · ETIII SA Fixture System (Ø3.2mm) · 2016-10-27
  • K103537 · ET III SA Ultra Wide System · 2011-03-10

A 510(k) clearance means the FDA found the device substantially equivalent to one already legally sold. It is not a quality ranking.

Recalls

We have not yet searched the recall databases system by system for Hiossen.

No result is not proof that no recall or field safety notice exists in any country.

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Educational information only. Choosing an implant requires an examination by a qualified dentist. Hiossen are trademarks of Hiossen. DentalImplantBrands is not affiliated with or endorsed by Hiossen.

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