510(k) Report

FDA applicant

Zentek Medical, LLC

Manalapan, NJ3 decisions2022–20250 recalls

FDA records 3 decisions for Zentek Medical, LLC (Manalapan, NJ) from 2022 to 2025: 3 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and DZE (Implant, Endosseous, Root-Form). Since 2016 its 510(k)s took a median of 393 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 3 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 Zentek Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 12023: 12025: 1
2022high 1 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Zentek Medical, LLC by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NHAAbutment, Implant, Dental, Endosseous2decisions
  • DZEImplant, Endosseous, Root-Form1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 393 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 147 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K221673Bonafix TiBaseZentek Medical, LLC · 20231cites it

What has FDA decided for it lately?

  • K251294Bonafix Implant AbutmentsZentek Medical, LLC · 2025
  • K221673Bonafix TiBaseZentek Medical, LLC · 2023
  • K213677Bonafix 2 PlusZentek Medical, LLC · 2022

All 3 as Zentek Medical, LLC →