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Dentium implant clearances and recalls: the public record

The FDA database lists 9 endosseous implant 510(k) clearances for Dentium, the first in 2004. Below are selected recent ones.

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FDA 510(k) clearances

  • K213599 · SuperLine · 2022-02-23
  • K171126 · Implantium II · 2017-09-07
  • K160965 · SuperLine · 2017-01-13
  • K153268 · NR Line Implant System · 2016-07-20
  • K041368 · Dentium Co., Ltd. Implantium · 2004-07-29

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 Dentium.

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. Dentium are trademarks of Dentium. DentalImplantBrands is not affiliated with or endorsed by Dentium.

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