510(k) Report

FDA applicant

A.B. Dental Device, Ltd.

Ashdod, IL4 decisions2017–20220 recalls

FDA records 4 decisions for A.B. Dental Device, Ltd. (Ashdod, IL) from 2017 to 2022: 4 510(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 343 days from receipt to decision, against 180 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 2 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 A.B. Dental Device, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2017: 12018: 12019: 12022: 1
2017high 1 (2017) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — A.B. Dental Device, Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like A.B. Dental Device, Ltd.’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?

  • NHAAbutment, Implant, Dental, Endosseous3decisions
  • DZEImplant, Endosseous, Root-Form1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 343 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 180 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd. · 20173cite it

What has FDA decided for it lately?

  • K202144A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd. · 2022
  • K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd. · 2019
  • K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd. · 2018
  • K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd. · 2017

All 4 as A.B. Dental Device, Ltd. →