Jdentalcare Srl: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Jdentalcare Srl” (first 2015, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 267 days. Since 2017 the median was 258 days, against 217 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 368 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 694 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 258 |
| 2025 | 1 | 164 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Jdentalcare Srl took a median 258 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 217 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 5 | 5 |
Review panels
- Dental (5)
Most recent Jdentalcare Srl 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251148 | JDEvolution Plus L and JDEvolution Plus LE | DZE | 2025-09-25 | 164 |
| K240143 | JDZygoma dental implants | DZE | 2024-10-11 | 267 |
| K233896 | JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus | DZE | 2024-08-16 | 249 |
| K182081 | JDentalCare Implant System JDIcon | DZE | 2020-06-26 | 694 |
| K143142 | JDENTALCARE Implant System | DZE | 2015-11-06 | 368 |
Recalls
openFDA lists no recalls under a recalling firm named Jdentalcare Srl.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Jdentalcare Srl?
FDA lists 5 510(k) clearances under the applicant name “Jdentalcare Srl” (first 2015, latest 2025), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Jdentalcare Srl?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jdentalcare Srl is 267 days. Since 2017: 258 days, versus 217 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Jdentalcare Srl?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 5).
Next steps
- See all 5 Jdentalcare Srl clearances with predicates and recalls
- Run predicate analysis for product code DZE, Jdentalcare Srl's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.