Neodent Implant System - GM Line

510(k) K163194

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

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Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK163194	Date14 Jul 2017Cleared	StatusActive

6 recalls · 4 ongoing · FDA

- Ongoing Z-3173-2026 FDA Class II initiated 12 Aug 2026
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
- Ongoing Z-2929-2026 FDA Class II initiated 13 Jul 2026 on shared 510(k) K163194
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume
2 recalls, same reason
- Ongoing Z-1863-2025 FDA Class II initiated 1 May 2025
- Ongoing Z-1862-2025 FDA Class II initiated 1 May 2025
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
- Terminated Z-0203-2022 FDA Class II initiated 11 Oct 2021
3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.
- Terminated Z-0455-2019 FDA Class II initiated 2 Oct 2018
Laser engraved label does not match with the item in the package

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)