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Neodent implant clearances and recalls: the public record

The FDA database lists 23 endosseous implant 510(k) clearances for Neodent, the first in 2010. Below are selected recent ones.

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FDA 510(k) clearances

  • K252090 · Pterygoid Indication for GM Helix Implants · 2025-12-12
  • K250271 · Neodent Implant System - Zirconia Implant System · 2025-08-18
  • K232099 · Neodent Implant System - GM Zygomatic Implant System · 2023-10-31
  • K223638 · Neodent Implant System - Helix Short Implant System · 2023-06-23
  • K220251 · Neodent Implant System - GM Narrow Implant System · 2022-09-06
  • K182620 · MRI Compatibility for Existing Neodent Implant System · 2019-01-18
  • K180536 · Neodent Implant System GM Line · 2018-08-30
  • K101207 · Neodent Implant System · 2010-08-02

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 Neodent.

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

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