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Astra Tech implant clearances and recalls: the public record

The FDA database lists 21 endosseous implant 510(k) clearances for Astra Tech, the first in 1994. Below are selected recent ones.

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FDA 510(k) clearances

  • K221094 · OmniTaper EV Dental Implants · 2022-11-16
  • K210610 · PrimeTaper EV Dental Implant · 2021-08-27
  • K130999 · OsseoSpeed Profile EV · 2013-10-25
  • K111287 · Astra Tech Implant System · 2011-09-26
  • K024111 · Astra Tech Implants - Dental System Fixture OsseoSpeed · 2003-06-10

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 Astra Tech.

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. Astra Tech are trademarks of Dentsply Sirona. DentalImplantBrands is not affiliated with or endorsed by Dentsply Sirona.

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