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◆ Mid-range

MegaGen implant clearances and recalls: the public record

The FDA database lists 24 endosseous implant 510(k) clearances for MegaGen, the first in 2005. Below are selected recent ones.

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FDA 510(k) clearances

  • K182448 · AnyRidge Octa 1 Implant System · 2019-10-09
  • K140091 · Xpeed AnyRidge Internal Implant System · 2014-12-12
  • K110955 · AnyRidge Internal Implant System · 2011-11-22

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

Recalls

Our searches of the FDA recall database for the MegaGen systems we cover found no recall records.

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. MegaGen, AnyRidge, Xpeed and KnifeThread are trademarks of MegaGen Implant Co., Ltd.

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