510(k) Report

FDA applicant

Newton Implant Systems, Inc.

San Diego, CA2 decisions2024–20240 recalls

FDA records 2 decisions for Newton Implant Systems, Inc. (San Diego, CA) in 2024: 2 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Newton Implant Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2024: 2
2024high 2 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Newton Implant Systems, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Newton Implant Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 20242cite it

What has FDA decided for it lately?

  • K221847Ni2 Implant SystemNewton Implant Systems, Inc. · 2024
  • K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024

All 2 as Newton Implant Systems, Inc. →