510(k) Report

FDA applicant

Tav Medical, Ltd.

Shlomi, IL3 decisions2018–20190 recalls

FDA records 3 decisions for Tav Medical, Ltd. (Shlomi, IL) from 2018 to 2019: 3 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Since 2016 its 510(k)s took a median of 389 days from receipt to decision, against 200 for FDA’s reviews in the same codes and years. Its devices cite 8 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 Tav Medical, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2018: 22019: 1
2018high 2 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Tav Medical, Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 389 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 200 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K172668W Zirconia ImplantsTav Medical, Ltd. · 20182cite it
  • K192053W Zirconia ImplantsTav Medical, Ltd. · 20191cites it
  • K170131TAV Medical Dental Implants SystemTav Medical, Ltd. · 20181cites it

What has FDA decided for it lately?

  • K192053W Zirconia ImplantsTav Medical, Ltd. · 2019
  • K172668W Zirconia ImplantsTav Medical, Ltd. · 2018
  • K170131TAV Medical Dental Implants SystemTav Medical, Ltd. · 2018

All 3 as Tav Medical, Ltd. →