510(k) Report

FDA applicant

Jdentalcare Srl

Modena, IT5 decisions2015–20250 recalls

FDA records 5 decisions for Jdentalcare Srl (Modena, IT) from 2015 to 2025: 5 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Since 2016 its 510(k)s took a median of 258 days from receipt to decision, against 222 for FDA’s reviews in the same codes and years. Its devices cite 5 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 Jdentalcare Srl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2015: 12020: 12024: 22025: 1
2015high 2 (2024) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Jdentalcare Srl by year, 2015–2026Sources: 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-Form5decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 258 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 222 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 2 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.

  • K143142JDENTALCARE Implant SystemJdentalcare Srl · 20151cites it
  • K182081JDentalCare Implant System JDIconJdentalcare Srl · 20201cites it

What has FDA decided for it lately?

  • K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl · 2025
  • K240143JDZygoma dental implantsJdentalcare Srl · 2024
  • K233896JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plusJdentalcare Srl · 2024
  • K182081JDentalCare Implant System JDIconJdentalcare Srl · 2020
  • K143142JDENTALCARE Implant SystemJdentalcare Srl · 2015

All 5 as Jdentalcare Srl →